Data / FDA device clearances / 510(k) special

FDA 510(k) special decisions: 983 since Nov 2024

Name: FDA 510(k) special decisions
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The full list. FDA 510(k) special decisions: 983 rows for $49.15, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 47 rows a month. The new rows come each week by email, $19 a month.

Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, decision type, date received and 6 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/decision/510k-special, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 30, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 983 device decisions of type 510(k) special from November 13, 2024 to October 30, 2026: 983 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 614 applicants. The newest, K263592 on October 30, 2026, is da Vinci Xi Surgical System (IS4000);da Vinci X Surgical System (IS4200) from Intuitive Surgical, Inc..

The request: Every new FDA 510(k) special decision, with the applicant, its address, the device and the product code. $10 of credit on sign-up, no card.

Get new clearances like these Watch a company

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

983Decisions
983510(k) and De Novo
0PMA
October 30, 2026Latest decision

Newest decisions

The newest 100 of 983, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

Decision date	Number	Device	Applicant	Location	Decision	Type	Product code	Source
October 30, 2026	K263592	da Vinci Xi Surgical System (IS4000);da Vinci X Surgical System (IS4200)	Intuitive Surgical, Inc.	California	Substantially Equivalent	510(k) special	NAY	accessdata.fda.gov
October 30, 2026	K263587	Arctic Sun Neonatal ArcticGel Pad	Medivance, Inc.	Colorado	Substantially Equivalent	510(k) special	DWJ	accessdata.fda.gov
October 30, 2026	K261886	VIVO (9002)	Catheter Precision, Inc.	South Carolina	Substantially Equivalent	510(k) special	DQK	accessdata.fda.gov
October 30, 2026	K260738	Safe AQ Easy Blood Glucose Monitoring System; Safe AQ Care Blood Glucose Monitoring System	Changsha Sinocare, Inc.	China	Substantially Equivalent	510(k) special	NBW	accessdata.fda.gov
October 29, 2026	K263648	Vitrea Advanced Visualization, Version 7.16	Canon Medical Informatics, Inc.	Minnesota	Substantially Equivalent	510(k) special	LLZ	accessdata.fda.gov
October 29, 2026	K263628	ELEOS Limb Salvage System with NanoCept® Technology (Proximal Tibia) (AM-25002200-C)	Onkos Surgical, Inc.	New Jersey	Substantially Equivalent	510(k) special	QZZ	accessdata.fda.gov
October 29, 2026	K263602	Arthrex Plates, Screws and Pins, and Washers	Arthrex, Inc.	Florida	Substantially Equivalent	510(k) special	HRS	accessdata.fda.gov
October 29, 2026	K263598	VasQ	Laminate Medical Technologies	Israel	Substantially Equivalent	510(k) special	QVQ	accessdata.fda.gov
October 29, 2026	K263596	DLP Coronary Ostial Cannulae	Medtronic, Inc.	Minnesota	Substantially Equivalent	510(k) special	DWF	accessdata.fda.gov
October 29, 2026	K263582	KeriFlex® MCP and PIP Finger Joint Prostheses	Keri Medical SA	Switzerland	Substantially Equivalent	510(k) special	KYJ	accessdata.fda.gov
October 29, 2026	K263530	V-Pro maX 2 Low Temperature Sterilization System	Steris	Ohio	Substantially Equivalent	510(k) special	MLR	accessdata.fda.gov
October 29, 2026	K262839	Cleerly ISCHEMIA	Cleerly, Inc.	Colorado	Substantially Equivalent	510(k) special	QXZ	accessdata.fda.gov
October 28, 2026	K263583	Tornier Humeral Reconstruction System (HRS) Tuberosity Body	Tornier, Inc.	Minnesota	Substantially Equivalent	510(k) special	KWS	accessdata.fda.gov
October 28, 2026	K263512	Luja female	Coloplast Corp.	Minnesota	Substantially Equivalent	510(k) special	EZD	accessdata.fda.gov
October 27, 2026	K263477	Arthrex FiberButton	Arthrex, Inc.	Florida	Substantially Equivalent	510(k) special	MBI	accessdata.fda.gov
October 27, 2026	K263461	Tendon Anchor	Smith & Nephew, Inc.	Massachusetts	Substantially Equivalent	510(k) special	GDW	accessdata.fda.gov
October 27, 2026	K260909	Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (SCP1); Sonoclot Coagulation &...	Sienco, Inc.	Colorado	Substantially Equivalent	510(k) special	JPA	accessdata.fda.gov
October 23, 2026	K263407	Tempo Plating System	Pace Surgical	Pennsylvania	Substantially Equivalent	510(k) special	HRS	accessdata.fda.gov
October 23, 2026	K263380	STAR Apollo Mapping System	Rhythm AI, Ltd.	United Kingdom	Substantially Equivalent	510(k) special	DQK	accessdata.fda.gov
October 23, 2026	K263348	Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor...	Smith & Nephew, Inc.	Massachusetts	Substantially Equivalent	510(k) special	MBI	accessdata.fda.gov
October 23, 2026	K261293	EASYMAX Voice Blood Glucose Monitoring System	EPS Bio Technology Corp.	Taiwan	Substantially Equivalent	510(k) special	NBW	accessdata.fda.gov
October 22, 2026	K263421	Veritas Shoulder System	restor3d, inc.	North Carolina	Substantially Equivalent	510(k) special	PHX	accessdata.fda.gov
October 22, 2026	K263333	Xpert Xpress CoV-2/Flu plus	Cepheid®	California	Substantially Equivalent	510(k) special	QOF	accessdata.fda.gov
October 21, 2026	K263422	Mint ACE Pump	Beta Bionics, Inc.	California	Substantially Equivalent	510(k) special	QFG	accessdata.fda.gov
October 21, 2026	K263352	TeKBrace Knotless Anchor	TheraMicro	Tennessee	Substantially Equivalent	510(k) special	MBI	accessdata.fda.gov
October 21, 2026	K263319	ACHM30 AtriClip FLEX-Mini LAA Exclusion System	AtriCure, Inc.	Ohio	Substantially Equivalent	510(k) special	PZX	accessdata.fda.gov
October 21, 2026	K260857	Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set	Sol-Millennium Medical, Inc.	Illinois	Substantially Equivalent	510(k) special	JKA	accessdata.fda.gov
October 16, 2026	K263266	Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set	Route 92 Medical, Inc.	California	Substantially Equivalent	510(k) special	NRY	accessdata.fda.gov
October 16, 2026	K263254	Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1)	Xiamen Compower Medical Tech. Co., Ltd.	China	Substantially Equivalent	510(k) special	BTM	accessdata.fda.gov
October 16, 2026	K263234	TMINI Miniature Robotic System	THINK Surgical, Inc.	California	Substantially Equivalent	510(k) special	OLO	accessdata.fda.gov
October 15, 2026	K263269	Park's Pectus System	Tdm Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	HRS	accessdata.fda.gov
October 15, 2026	K262097	MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621)	Carl Zeiss Meditec Cataract Technologies	Nevada	Substantially Equivalent	510(k) special	HQC	accessdata.fda.gov
October 14, 2026	K263208	Vantage Lumbar Decompression Kit	SurGenTec, LLC	Florida	Substantially Equivalent	510(k) special	HRX	accessdata.fda.gov
October 13, 2026	K263257	Electrically Powered Wheelchair (YC-01)	Yurob Rehabilitation Medical Co., Ltd.	China	Substantially Equivalent	510(k) special	ITI	accessdata.fda.gov
October 9, 2026	K263154	CarboClear® Cervical Navigated Instruments	CarboFix Orhtopedics , Ltd.	Israel	Substantially Equivalent	510(k) special	OLO	accessdata.fda.gov
October 7, 2026	K263159	prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments	Centinel Spine, LLC	Pennsylvania	Substantially Equivalent	510(k) special	QLQ	accessdata.fda.gov
October 5, 2026	K262813	InkSpace Imaging Small Body Array (SBA12PH15x)	Inkspace Imaging, Inc.	California	Substantially Equivalent	510(k) special	MOS	accessdata.fda.gov
October 2, 2026	K263120	Xpert Xpress CoV-2/Flu plus	Cepheid®	California	Substantially Equivalent	510(k) special	QOF	accessdata.fda.gov
October 2, 2026	K263116	OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts	OsteoCentric Technologies	Utah	Substantially Equivalent	510(k) special	HWC	accessdata.fda.gov
October 2, 2026	K263113	ZSAlign Cervical Interbody System	ZSFab, Inc.	Massachusetts	Substantially Equivalent	510(k) special	OVE	accessdata.fda.gov
October 2, 2026	K263086	AltiVate Reverse® Glenosphere with RAVN Technology	Encore Medical L.P.	Texas	Substantially Equivalent	510(k) special	PHX	accessdata.fda.gov
October 2, 2026	K263083	Response Ortho Smart Fixator - Hexapod System	Response Ortho Solutions, LLC	Florida	Substantially Equivalent	510(k) special	KTT	accessdata.fda.gov
October 2, 2026	K262412	Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630)	Barco NV	Belgium	Substantially Equivalent	510(k) special	PGY	accessdata.fda.gov
October 2, 2026	K261611	TDM Large Bone Plate and Screw System	Tdm Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	HRS	accessdata.fda.gov
October 2, 2026	K261217	AnyPlus II Spinal Fixation System	GS Medical Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	NKB	accessdata.fda.gov
October 2, 2026	K260689	CVS Advanced PLUS Blood Glucose Monitoring System	I-Sens, Inc.	South Korea	Substantially Equivalent	510(k) special	NBW	accessdata.fda.gov
October 1, 2026	K263092	Dual Stage Venous Cannulae	Sorin Group Italia S.R.L.	Italy	Substantially Equivalent	510(k) special	DWF	accessdata.fda.gov
October 1, 2026	K263062	NOVIX Pedicle Screw System	Tdm Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	NKB	accessdata.fda.gov
October 1, 2026	K263016	Intra-Operative Positioning System (IOPS) and IOPS Visionary System	Centerline Biomedical	Ohio	Substantially Equivalent	510(k) special	DQK	accessdata.fda.gov
October 1, 2026	K262473	NEXUS® Hip Stem	Microport Orthopedics, Inc.	Tennessee	Substantially Equivalent	510(k) special	LZO	accessdata.fda.gov
September 30, 2026	K263172	SAS MIS Pelvic Incidence Rods	Spinal Alignment Solutions, Inc.	North Carolina	Substantially Equivalent	510(k) special	NKB	accessdata.fda.gov
September 30, 2026	K263035	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A...	Centers for Disease Control and Prevention	Georgia	Substantially Equivalent	510(k) special	OZE	accessdata.fda.gov
September 30, 2026	K263033	Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)	Fussen Technology Co., Ltd.	China	Substantially Equivalent	510(k) special	OAS	accessdata.fda.gov
September 30, 2026	K262621	Rapid Barostat Bag (RBB) Pump and Catheter System	Mui Scientific, Inc.	Canada	Substantially Equivalent	510(k) special	FFX	accessdata.fda.gov
September 30, 2026	K261975	Braun Aura 7 (6041)	CyDen Limited	United Kingdom	Substantially Equivalent	510(k) special	OHT	accessdata.fda.gov
September 29, 2026	K263073	Fast Absorbing PGLA	Riverpoint Medical, LLC	Oregon	Substantially Equivalent	510(k) special	GAM	accessdata.fda.gov
September 25, 2026	K262983	EsTemp Implant	Spident Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	EMA	accessdata.fda.gov
September 25, 2026	K262975	Arthrex Beaming System	Arthrex, Inc.	Florida	Substantially Equivalent	510(k) special	HWC	accessdata.fda.gov
September 25, 2026	K261977	Braun Aura 9 (6042)	Cyden Limited	United Kingdom	Substantially Equivalent	510(k) special	OHT	accessdata.fda.gov
September 24, 2026	K263010	ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress	inomed Medizintechnik GmbH	Germany	Substantially Equivalent	510(k) special	GWF	accessdata.fda.gov
September 24, 2026	K262955	OsseoFit Stemless Shoulder System	Zimmer, Inc.	Indiana	Substantially Equivalent	510(k) special	PKC	accessdata.fda.gov
September 24, 2026	K260214	STA® - Liquid Anti-Xa	Diagnostica Stago, Inc.	New Jersey	Substantially Equivalent	510(k) special	KFF	accessdata.fda.gov
September 23, 2026	K263049	SABER-C System	Elevation Spine	California	Substantially Equivalent	510(k) special	OVE	accessdata.fda.gov
September 22, 2026	K263054	BIOFIRE Respiratory Panel 2.1 (RP2.1)	Biofire Diagnostics	Utah	Substantially Equivalent	510(k) special	QOF	accessdata.fda.gov
September 21, 2026	K262982	Core·it Dual	Spident Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	EBF	accessdata.fda.gov
September 21, 2026	K260940	BellaTek Bars	ZimVie US Corp, LLC	Florida	Substantially Equivalent	510(k) special	NHA	accessdata.fda.gov
September 18, 2026	K262817	CrossFAST Integrated Microcatheter Advanced Delivery System	Vantis Vascular, Inc.	California	Substantially Equivalent	510(k) special	DQY	accessdata.fda.gov
September 18, 2026	K262098	EnHAnce PEEK Bunion System	Nvision Biomedical Technologies	Texas	Substantially Equivalent	510(k) special	HRS	accessdata.fda.gov
September 17, 2026	K262913	Protégé EverFlex Self-expanding Peripheral Stent System	Medtronic, Inc.	Minnesota	Substantially Equivalent	510(k) special	FGE	accessdata.fda.gov
September 17, 2026	K261959	Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch...	Stryker Instruments	Michigan	Substantially Equivalent	510(k) special	GEI	accessdata.fda.gov
September 16, 2026	K262877	SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser...	Olympus Surgical Technologies America	Massachusetts	Substantially Equivalent	510(k) special	GEX	accessdata.fda.gov
September 15, 2026	K262963	TMC Implant Fixation System	Treace Medical Concepts, Inc.	Florida	Substantially Equivalent	510(k) special	HRS	accessdata.fda.gov
September 15, 2026	K260145	YJ-K1K2 Wheelchair (YJ-013F)	Zhenjiang Assure Medical Equipment Co., Ltd.	China	Substantially Equivalent	510(k) special	IOR	accessdata.fda.gov
September 15, 2026	K260144	Reclining wheelchair (YJ-013L)	Zhenjiang Assure Medical Equipment Co., Ltd.	China	Substantially Equivalent	510(k) special	IOR	accessdata.fda.gov
September 15, 2026	K260141	Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)	Zhenjiang Assure Medical Equipment Co., Ltd.	China	Substantially Equivalent	510(k) special	IOR	accessdata.fda.gov
September 12, 2026	K260133	CADDIE	Odin Medical Limited	United Kingdom	Substantially Equivalent	510(k) special	QNP	accessdata.fda.gov
September 11, 2026	K262874	CraniUS Plate	CraniUS, LLC	Maryland	Substantially Equivalent	510(k) special	GWO	accessdata.fda.gov
September 11, 2026	K262861	PureLift Pro Max	Xtreem Pulse, LLC	New York	Substantially Equivalent	510(k) special	NFO	accessdata.fda.gov
September 11, 2026	K260410	Single Use Ureteral Access Sheath	Zhejiang Chuangxiang Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) special	FED	accessdata.fda.gov
September 11, 2026	K253063	Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach...	Vitaltec Corporation	Taiwan	Substantially Equivalent	510(k) special	BTO	accessdata.fda.gov
September 10, 2026	K261929	Upper Arm Blood pressure monitor (BP7155D)	OMRON Healthcare, Inc.	Illinois	Substantially Equivalent	510(k) special	DXN	accessdata.fda.gov
September 10, 2026	K261696	ACUNAV Luxera 4D ICE Catheter	Siemens Medical Solutions USA, Inc.	Washington	Substantially Equivalent	510(k) special	OBJ	accessdata.fda.gov
September 9, 2026	K262542	Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination...	Top Glove Sdn. Bhd.	Malaysia	Substantially Equivalent	510(k) special	LZA	accessdata.fda.gov
September 8, 2026	K260312	Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation...	Gmp Medicare Sdn. Bhd.	Malaysia	Substantially Equivalent	510(k) special	LZA	accessdata.fda.gov
September 4, 2026	K262828	KHEIRON® Spinal Fixation System, including patient specific K-ROD	S.m.a.i.o	France	Substantially Equivalent	510(k) special	NKB	accessdata.fda.gov
September 4, 2026	K262277	70 NeuGlide Catheter	Piraeus Medical, Inc.	Minnesota	Substantially Equivalent	510(k) special	QJP	accessdata.fda.gov
September 3, 2026	K262769	Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)	Orthocon, Inc.	Connecticut	Substantially Equivalent	510(k) special	MTJ	accessdata.fda.gov
September 2, 2026	K262809	ArthroTAK Tendon Anchor Kit	ArthroTAK, LLC	Montana	Substantially Equivalent	510(k) special	MBI	accessdata.fda.gov
August 31, 2026	K262788	Nova HD+	Aura Wellness, LLC	Kentucky	Substantially Equivalent	510(k) special	SGT	accessdata.fda.gov
August 31, 2026	K262747	ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0	Abbott Diagnostics Scarborough, Inc.	Maine	Substantially Equivalent	510(k) special	OCC	accessdata.fda.gov
August 31, 2026	K262658	Automatic Digital Blood Pressure monitor (LD-526)	Honsun (Nantong) Co., Ltd.	China	Substantially Equivalent	510(k) special	DXN	accessdata.fda.gov
August 28, 2026	K262735	LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)	Medtronic, Inc.	Minnesota	Substantially Equivalent	510(k) special	MXD	accessdata.fda.gov
August 28, 2026	K262722	Primal K-Wire (P99-193-1410)	Paragon 28, Inc.	Colorado	Substantially Equivalent	510(k) special	HTY	accessdata.fda.gov
August 28, 2026	K262013	Kiba CTO Crossing Catheter	Reflow Medical, Inc.	California	Substantially Equivalent	510(k) special	PDU	accessdata.fda.gov
August 27, 2026	K262744	GenesisX RMN	Stereotaxis, Inc.	Missouri	Substantially Equivalent	510(k) special	DXX	accessdata.fda.gov
August 27, 2026	K262677	Iconix Knotless T	Riverpoint Medical	Oregon	Substantially Equivalent	510(k) special	MBI	accessdata.fda.gov
August 27, 2026	K262654	Dexus Prosthetic System (MSL2, MSR2)	Zhejiang Qiangnao Technology Co.,Ltd	China	Substantially Equivalent	510(k) special	GXY	accessdata.fda.gov
August 27, 2026	K262268	Optiflow Oxygen Kit (AA484J)	Fisher and Paykel Healthcare Limited	New Zealand	Substantially Equivalent	510(k) special	BTT	accessdata.fda.gov
August 27, 2026	K262104	Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)	Ram.Shaw Pte., Ltd.	Singapore	Substantially Equivalent	510(k) special	LRK	accessdata.fda.gov
August 26, 2026	K262595	VariLift-C Cervical Interbody Fusion System	Wenzel Spine, Inc.	Texas	Substantially Equivalent	510(k) special	ODP	accessdata.fda.gov

Applicants with the most decisions

Applicant	Decisions	Latest
Boston Scientific Corporation	15	July 24, 2026
Arthrex, Inc.	13	October 29, 2026
Medtronic, Inc.	11	October 29, 2026
Abbott Medical	10	July 15, 2026
CenterPoint Systems, LLC	9	July 29, 2026
STERIS Corporation	9	April 8, 2026
Cepheid®	7	October 22, 2026
Promisemed Hangzhou Meditech Co., Ltd.	7	August 25, 2026
Alembic, LLC	7	August 12, 2026
Stryker Endoscopy	7	July 30, 2026
Smith & Nephew, Inc.	6	October 27, 2026
SurGenTec, LLC	6	October 14, 2026
Sorin Group Italia S.R.L.	6	October 1, 2026
S.m.a.i.o	6	September 4, 2026
L&K BIOMED Co., Ltd.	6	August 18, 2026
TriMed, Inc.	6	August 12, 2026
Philips Ultrasound, LLC	6	August 4, 2026
Siemens Medical Solutions USA, Inc.	5	September 10, 2026
Orthocon, Inc.	5	September 3, 2026
Riverpoint Medical	5	August 27, 2026

By panel

Panel	Decisions	Latest
Orthopedic	202	October 29, 2026
Cardiovascular	188	October 30, 2026
General, Plastic Surgery	109	October 27, 2026
Radiology	104	October 29, 2026
Neurology	74	October 16, 2026
General Hospital	67	October 29, 2026
Gastroenterology, Urology	62	October 30, 2026
Dental	37	September 25, 2026
Physical Medicine	24	October 13, 2026
Microbiology	21	October 22, 2026
Unknown	17	September 3, 2026
Obstetrics/Gynecology	16	March 4, 2026
Clinical Chemistry	15	October 30, 2026
Anesthesiology	13	October 16, 2026
Hematology	11	October 27, 2026
Ear, Nose, Throat	10	August 26, 2026
Ophthalmic	8	October 15, 2026
Clinical Toxicology	3	July 9, 2025
Immunology	1	March 30, 2026
Pathology	1	December 17, 2024

By state or country

State or country	Decisions	Latest
California	151	October 30, 2026
China	88	October 30, 2026
South Korea	52	October 15, 2026
Massachusetts	48	October 27, 2026
Minnesota	47	October 29, 2026
Florida	41	October 29, 2026
Israel	35	October 29, 2026
Utah	32	October 2, 2026
France	30	September 4, 2026
Tennessee	25	October 21, 2026
Pennsylvania	23	October 23, 2026
Texas	23	October 2, 2026
Germany	23	September 24, 2026
Ohio	21	October 29, 2026
Italy	18	October 1, 2026
Switzerland	17	October 29, 2026
New York	17	September 11, 2026
Colorado	16	October 30, 2026
Taiwan	16	October 23, 2026
Ireland	15	August 12, 2026
North Carolina	13	October 22, 2026
Illinois	13	October 21, 2026
Canada	13	September 30, 2026
Georgia	12	September 30, 2026
New Jersey	11	October 29, 2026

Where FDA publishes these decisions

CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.