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Data / FDA device clearances / Anesthesiology

FDA Anesthesiology device clearances: 279 since Nov 2024

The full list. FDA anesthesiology device clearances and approvals: 279 rows for $13.95, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 11 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, date received, device type 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/panel/anesthesiology, 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 279 device decisions in anesthesiology (FDA review panel) from November 12, 2024 to October 30, 2026: 205 510(k) clearances and De Novo grants and 74 PMA approvals and supplements, for 168 applicants. The newest, K253095 on October 30, 2026, is ULSPIRA TS™ Nitric Oxide Therapy System from Airgas Therapeutics, LLC.

The request: Every new FDA clearance or approval of a anesthesiology device, with the applicant, its address and the product code. $10 of credit on sign-up, no card.

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.

  • 279Decisions
  • 205510(k) and De Novo
  • 74PMA
  • October 30, 2026Latest decision

Newest decisions

The newest 100 of 279, 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 dateNumberDeviceApplicantLocationDecisionTypeProduct codeSource
October 30, 2026K253095ULSPIRA TS™ Nitric Oxide Therapy SystemAirgas Therapeutics, LLCPennsylvaniaSubstantially Equivalent510(k) traditionalMRNaccessdata.fda.gov
October 26, 2026P230042/S010Optune LuaNovocure, GmbH30-day notice acceptedPMA 30-day noticeSDAaccessdata.fda.gov
October 26, 2026P130008/S144INSPIRE II UPPER AIRWAY STIMULATORInspire Medical SystemsMinnesotaApprovedPMA real-time process supplementMNQaccessdata.fda.gov
October 26, 2026K260671RP Check (RP01)MD Diagnostics, Ltd.United KingdomSubstantially Equivalent510(k) traditionalCAPaccessdata.fda.gov
October 23, 2026K260251BreathCare PAP III (YH-390N)Suzhou Yuyue Medical Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalBZDaccessdata.fda.gov
October 22, 2026P130008/S147Model 3150 IPGInspire Medical SystemsMinnesota30-day notice acceptedPMA 30-day noticeMNQaccessdata.fda.gov
October 16, 2026K263254Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1)Xiamen Compower Medical Tech. Co., Ltd.ChinaSubstantially Equivalent510(k) specialBTMaccessdata.fda.gov
October 13, 2026P130008/S146Model 3150 IPGInspire Medical SystemsMinnesota30-day notice acceptedPMA 30-day noticeMNQaccessdata.fda.gov
October 11, 2026K253717Helo™ ReturnEndovascular Engineering, Inc.CaliforniaSubstantially Equivalent510(k) traditionalSHJaccessdata.fda.gov
October 5, 2026K261939GlucommanderGlytec, LLCSouth CarolinaSubstantially Equivalent510(k) traditionalNDCaccessdata.fda.gov
September 28, 2026P850064/S056LifePulse® High Frequency VentilatorBunnell, Inc.UtahApprovedPMA 180-day supplementLSZaccessdata.fda.gov
September 25, 2026P240012/S008AeroPace® SystemLungpacer Medical USA, Inc.PennsylvaniaApprovedPMA real-time process supplementSDLaccessdata.fda.gov
September 25, 2026K261372Profoject™ LOR SyringeCMT Health PTE., Ltd.SingaporeSubstantially Equivalent510(k) traditionalCAZaccessdata.fda.gov
September 25, 2026K261262Altis Full Face MaskRespironics, Inc.PennsylvaniaSubstantially Equivalent510(k) traditionalBZDaccessdata.fda.gov
September 25, 2026K260140Aevice Wheeze Detection ModuleAevice Health Pte. , Ltd.SingaporeSubstantially Equivalent510(k) traditionalPHZaccessdata.fda.gov
September 24, 2026K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbHGermanySubstantially Equivalent510(k) traditionalMNRaccessdata.fda.gov
September 23, 2026K254289Portable Oxygen Concentrator (OX-1A-E, OX-1B)Oxytek Medical Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalCAWaccessdata.fda.gov
September 18, 2026K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalCAFaccessdata.fda.gov
September 16, 2026K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.CaliforniaSubstantially Equivalent510(k) traditionalBZKaccessdata.fda.gov
September 11, 2026P180002/S032Zephyr Endobronchial Valve SystemPulmonx CorporationCaliforniaApprovedPMA real-time process supplementNJKaccessdata.fda.gov
September 11, 2026K253063Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach...Vitaltec CorporationTaiwanSubstantially Equivalent510(k) specialBTOaccessdata.fda.gov
September 3, 2026K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc.OhioSubstantially Equivalent510(k) traditionalBTRaccessdata.fda.gov
August 28, 2026P130008/S136Model 4063 Inspire Stimulation LeadInspire Medical SystemsMinnesotaApprovedPMA 135-day supplementMNQaccessdata.fda.gov
August 28, 2026P130008/S123INSPIRE II UPPER AIRWAY STIMULATORInspire Medical SystemsMinnesotaApprovedPMA 135-day supplementMNQaccessdata.fda.gov
August 27, 2026K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare LimitedNew ZealandSubstantially Equivalent510(k) specialBTTaccessdata.fda.gov
August 27, 2026K261360EasyCare Tx 2Resmed CorpCaliforniaSubstantially Equivalent510(k) traditionalMODaccessdata.fda.gov
August 24, 2026K260604BiWaze Clear SystemAbmrc, LLCMinnesotaSubstantially Equivalent510(k) traditionalNHJaccessdata.fda.gov
August 20, 2026P180007/S016Spiration® Valve SystemGyrus Acmi, Inc.WashingtonApprovedPMA 180-day supplementNJKaccessdata.fda.gov
August 20, 2026K260242CPETWise PlatformMedibyt , Ltd.IsraelSubstantially Equivalent510(k) traditionalBTYaccessdata.fda.gov
August 20, 2026K253807Valence InVent Xtend™ (CVG-4101-VXA)Convergence Medical Sciences , Ltd.CanadaSubstantially Equivalent510(k) traditionalMODaccessdata.fda.gov
August 17, 2026P130008/S143Inspire Upper Airway Stimulation (UAS) SystemInspire Medical SystemsMinnesota30-day notice acceptedPMA 30-day noticeMNQaccessdata.fda.gov
August 14, 2026K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)BMC Medical Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalCAWaccessdata.fda.gov
August 13, 2026K261499TrachFlushAw Technologies ApsDenmarkSubstantially Equivalent510(k) traditionalBSKaccessdata.fda.gov
August 12, 2026K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationJapanSubstantially Equivalent510(k) traditionalCCKaccessdata.fda.gov
August 11, 2026P130008/S142Model 4063 Inspire Stimulation LeadInspire Medical SystemsMinnesota30-day notice acceptedPMA 30-day noticeMNQaccessdata.fda.gov
July 31, 2026K254042WatchPAT SWItamar Medical , Ltd.IsraelSubstantially Equivalent510(k) traditionalMNRaccessdata.fda.gov
July 30, 2026P240024/S004Genio® System 2.1Nyxoah S.A.ApprovedPMA real-time process supplementMNQaccessdata.fda.gov
July 30, 2026K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter LabsTexasSubstantially Equivalent510(k) traditionalCCLaccessdata.fda.gov
July 23, 2026K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalBZDaccessdata.fda.gov
July 20, 2026K261011Sleep Apnea Feature (v2.0)Samsung Electronics Co., Ltd.South KoreaSubstantially Equivalent510(k) traditionalQZWaccessdata.fda.gov
July 15, 2026K260050WRAP SystemHuneo, LLCOhioSubstantially Equivalent510(k) traditionalMNRaccessdata.fda.gov
July 14, 2026K261633VisuBreathAffirm Medical Technologies II, LLCCaliforniaSubstantially Equivalent510(k) traditionalCCKaccessdata.fda.gov
July 10, 2026P130008/S140Model 3150 Implantable Pulse Generator (IPG)Inspire Medical SystemsMinnesotaApprovedPMA 135-day supplementMNQaccessdata.fda.gov
July 1, 2026P230042/S008Optune Lua®Novocure, GmbHApprovedPMA real-time process supplementSDAaccessdata.fda.gov
June 25, 2026K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalBSZaccessdata.fda.gov
June 25, 2026K253274BedDot (G1)Intelligent Dots, LLCGeorgiaSubstantially Equivalent510(k) traditionalBZQaccessdata.fda.gov
June 23, 2026K253180Microlife Digital Peak Flow Meter, Model PF200B (PF200B)Microlife CorporationTaiwanSubstantially Equivalent510(k) traditionalBZHaccessdata.fda.gov
June 22, 2026P240012/S007AeroPace® SystemLungpacer Medical USA, Inc.PennsylvaniaApprovedPMA 180-day supplementSDLaccessdata.fda.gov
June 22, 2026P240012/S006AeroPace® SystemLungpacer Medical USA, Inc.PennsylvaniaApprovedPMA real-time process supplementSDLaccessdata.fda.gov
June 22, 2026K253148RX-1 SleepVivaquant, Inc. Dba Rhythm ExpressMinnesotaSubstantially Equivalent510(k) traditionalMNRaccessdata.fda.gov
June 18, 2026P250013/S002aura6000™ systemLivaNova USA, Inc.TexasApprovedPMA 180-day supplementMNQaccessdata.fda.gov
June 18, 2026K252066inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™...Vincent Healthcare Products LimitedHong KongSubstantially Equivalent510(k) traditionalBZEaccessdata.fda.gov
June 18, 2026DEN250025Syncron-EAutonomous Healthcare, Inc.CaliforniaUnknownDe NovoQVCaccessdata.fda.gov
June 17, 2026P180002/S031Zephyr Endobronchial Valve (EBV) SystemPulmonx CorporationCalifornia30-day notice acceptedPMA 30-day noticeNJKaccessdata.fda.gov
June 17, 2026K252399Portable Oxygen ConcentratorHonsun (Nantong) Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalCAWaccessdata.fda.gov
June 16, 2026K253001KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)Hunan Ruijiong Biotech Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalNHJaccessdata.fda.gov
June 12, 2026K253437Spiro-VISTASpiro RoboticsCaliforniaSubstantially Equivalent510(k) traditionalBTRaccessdata.fda.gov
June 11, 2026K251326Respiration Rate algorithmEdwards Lifesciences, LLCCaliforniaSubstantially Equivalent510(k) traditionalBZQaccessdata.fda.gov
June 8, 2026P240024/S003Genio® System 2.1Nyxoah S.A.ApprovedPMA real-time process supplementMNQaccessdata.fda.gov
June 4, 2026K253553OrionResmed CorpCaliforniaSubstantially Equivalent510(k) traditionalBZDaccessdata.fda.gov
June 2, 2026K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.PolandSubstantially Equivalent510(k) traditionalCAFaccessdata.fda.gov
June 2, 2026K252844Tyto Insights for Wheeze Detection (with PCCP)Tyto Care , Ltd.IsraelSubstantially Equivalent510(k) traditionalPHZaccessdata.fda.gov
May 29, 2026K253119CoSense ETCO MonitorCapnia, Inc.CaliforniaSubstantially Equivalent510(k) traditionalCCJaccessdata.fda.gov
May 29, 2026K252965Oxygen Concentrator (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalCAWaccessdata.fda.gov
May 29, 2026K252802Peak Flow Meter (PF-10(BR-PEF231))Shenzhen Bi-Rich Medical Devices Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalBZHaccessdata.fda.gov
May 28, 2026P130008/S139Inspire Model 4063 Leads; Inspire Model 4340 LeadsInspire Medical SystemsMinnesota30-day notice acceptedPMA 30-day noticeMNQaccessdata.fda.gov
May 27, 2026K254104ResScan EssentialsResmed CorpCaliforniaSubstantially Equivalent510(k) traditionalBZDaccessdata.fda.gov
May 27, 2026K254102GlucommanderGlytec, LLCSouth CarolinaSubstantially Equivalent510(k) traditionalNDCaccessdata.fda.gov
May 22, 2026K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric...Senzime ABSwedenSubstantially Equivalent510(k) specialKOIaccessdata.fda.gov
May 21, 2026K252746Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)Drägerwerk AG Co. KgaaGermanySubstantially Equivalent510(k) traditionalBSZaccessdata.fda.gov
May 21, 2026K251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.New YorkSubstantially Equivalent510(k) traditionalBZDaccessdata.fda.gov
May 15, 2026K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd.MalaysiaSubstantially Equivalent510(k) traditionalCAHaccessdata.fda.gov
May 12, 2026K260051CorVision® (91-205-Z0014)CorVent® Medical, Inc.North DakotaSubstantially Equivalent510(k) traditionalMODaccessdata.fda.gov
May 7, 2026P850064/S058LifePulse High Frequency Ventilator (LifePulse HFV) Model 204Bunnell, Inc.Utah30-day notice acceptedPMA 30-day noticeLSZaccessdata.fda.gov
May 7, 2026P180007/S015Spiration Valve System (SVS)Gyrus Acmi, Inc.Washington30-day notice acceptedPMA 30-day noticeNJKaccessdata.fda.gov
May 7, 2026K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaGermanySubstantially Equivalent510(k) traditionalCBKaccessdata.fda.gov
May 1, 2026K260910EndoTool IV Cloud 1.0Glooko, Inc.CaliforniaSubstantially Equivalent510(k) traditionalNDCaccessdata.fda.gov
May 1, 2026K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCColoradoSubstantially Equivalent510(k) traditionalCCKaccessdata.fda.gov
April 30, 2026P250013/S001aura6000™ systemLivaNova USA, Inc.TexasApprovedPMA 180-day supplementMNQaccessdata.fda.gov
April 30, 2026K252849AffloVest® Mobile Airway Clearance TherapyTactile MedicalMinnesotaSubstantially Equivalent510(k) traditionalBYIaccessdata.fda.gov
April 30, 2026K251583Ambu® Virobac II® Exhalation FilterAmbu A/SDenmarkSubstantially Equivalent510(k) traditionalCAHaccessdata.fda.gov
April 29, 2026K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalBZDaccessdata.fda.gov
April 27, 2026K252628CASSIEWesper, Inc.New YorkSubstantially Equivalent510(k) traditionalMNRaccessdata.fda.gov
April 23, 2026K252407OxyGo Portable Oxygen Concentrator (1400-7000)Mv Life, LLCFloridaSubstantially Equivalent510(k) traditionalCAWaccessdata.fda.gov
April 17, 2026K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)MinnesotaSubstantially Equivalent510(k) traditionalBZDaccessdata.fda.gov
April 16, 2026P130008/S138Inspire V Printed Circuit Board Assembly (PCBA) Test System SWInspire Medical SystemsMinnesota30-day notice acceptedPMA 30-day noticeMNQaccessdata.fda.gov
April 14, 2026K252663Inbentus VersatileIconic Solutions by Murcia, SLSpainSubstantially Equivalent510(k) traditionalCBKaccessdata.fda.gov
April 13, 2026K254078HVT 2.0Vapotherm, Inc.New HampshireSubstantially Equivalent510(k) traditionalBTTaccessdata.fda.gov
April 8, 2026K251889myAirResmed CorpCaliforniaSubstantially Equivalent510(k) traditionalMNSaccessdata.fda.gov
April 6, 2026K252182SV70 Ventilator (SV70)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalMNTaccessdata.fda.gov
March 26, 2026K253549DeVilbiss 5 Liter Oxygen Concentrator (555)Devilbiss Healthcare, LLCPennsylvaniaSubstantially Equivalent510(k) traditionalCAWaccessdata.fda.gov
March 25, 2026K253322Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT /...Medline Industries, LPIllinoisSubstantially Equivalent510(k) traditionalBZEaccessdata.fda.gov
March 20, 2026K251950Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube...Hangzhou Tappa Medical Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalCBIaccessdata.fda.gov
March 18, 2026P250013aura6000™ systemLivaNova USA, Inc.TexasApprovedPMA original approvalMNQaccessdata.fda.gov
March 17, 2026P180002/S030Zephyr Endobronchial Valve (EBV) SystemPulmonx CorporationCalifornia30-day notice acceptedPMA 30-day noticeNJKaccessdata.fda.gov
March 17, 2026K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.TaiwanSubstantially Equivalent510(k) traditionalMNSaccessdata.fda.gov
March 13, 2026P200044/S013LungFit PHBeyond Air, Inc.New York30-day notice acceptedPMA 30-day noticeQTBaccessdata.fda.gov
March 13, 2026P130008/S137Model 3150 Implantable Pulse Generator (IPG)Inspire Medical SystemsMinnesota30-day notice acceptedPMA 30-day noticeMNQaccessdata.fda.gov
March 12, 2026P010047/S073PROGEL™ Pleural Air Leak SealantNeomend, Inc.California30-day notice acceptedPMA 30-day noticeNBEaccessdata.fda.gov
March 12, 2026K251888VPAP Pediatric Face MaskHsiner Co., Ltd.TaiwanSubstantially Equivalent510(k) traditionalCBKaccessdata.fda.gov

Applicants with the most decisions

ApplicantDecisionsLatest
Inspire Medical Systems30October 26, 2026
Lungpacer Medical USA, Inc.9September 25, 2026
Novocure, GmbH7October 26, 2026
Resmed Corp6August 27, 2026
Pulmonx Corporation5September 11, 2026
Nyxoah S.A.5July 30, 2026
Covidien, LLC5May 1, 2026
Fisher & Paykel Healthcare, Ltd.5December 19, 2025
PAJUNK GmbH Medizintechnologie5July 1, 2025
Breas Medical AB5May 20, 2025
Beyond Air, Inc.4March 13, 2026
Neomend, Inc.4March 12, 2026
Bunnell, Inc.3September 28, 2026
BMC Medical Co., Ltd.3August 14, 2026
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.3June 25, 2026
LivaNova USA, Inc.3June 18, 2026
Medline Industries, LP3March 25, 2026
Huxley Medical3December 10, 2025
ZOLL Medical Corporation3July 23, 2025
Airgas Therapeutics, LLC2October 30, 2026

By decision type

Decision typeDecisionsLatest
510(k) traditional191October 30, 2026
PMA 30-day notice36October 26, 2026
PMA real-time process supplement17October 26, 2026
510(k) special13October 16, 2026
PMA 180-day supplement12September 28, 2026
PMA 135-day supplement5August 28, 2026
PMA original approval3March 18, 2026
De Novo1June 18, 2026
PMA special supplement1February 14, 2025

By state or country

State or countryDecisionsLatest
Minnesota35October 26, 2026
China35October 23, 2026
California34October 11, 2026
Pennsylvania16October 30, 2026
Germany11September 24, 2026
Taiwan11September 11, 2026
Israel8August 20, 2026
New Zealand7August 27, 2026
New York7May 21, 2026
Georgia6June 25, 2026
Sweden6May 22, 2026
United Kingdom5October 26, 2026
Texas5July 30, 2026
Colorado5May 1, 2026
Massachusetts5December 19, 2025
Utah4September 28, 2026
Singapore4September 25, 2026
Illinois4March 25, 2026
Australia4February 23, 2026
Ohio3September 3, 2026
Washington3August 20, 2026
Denmark3August 13, 2026
South Korea3July 20, 2026
France3August 12, 2025
North Carolina3April 29, 2025

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.