Data / Medical devices / United States / Solventum US LLC

Solventum US LLC: FDA-registered device maker in Brookings, SD, United States, 27 510(k) clearances

Name: Solventum US LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Solventum US LLC is registered with the FDA (registration 3031757047) in Brookings, SD, United States. It lists 25 device types. The FDA files 27 510(k) clearances under its listings, the newest dated October 10, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Solventum US LLC

FDA registration number: 3031757047
Address: 601 22nd Ave S, Brookings, SD, United States, 57006
Owner or operator: Solventum US LLC (10091183)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: March 3, 1995
Registered through: 2026
Brand names listed: 3M, 3M¿ Attest¿ Auto-Reader, 3M¿ Ioban¿ 2, 3M¿ Steri-Drape¿ Ioban¿ 2, Attest Rapid Readout 1291, Defib Pads

Devices it lists

Device	Product code	Class	Role	Source
A Chemical Vapor Sterilization Multivariable Chemical Indicator	QKM	2	Manufacturer	accessdata.fda.gov
Antimicrobial Drapes	PLY	2	Manufacturer	accessdata.fda.gov
Bag, Intestine	KGY	1	Manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Manufacturer	accessdata.fda.gov
Bandage, Liquid	KMF	1	Manufacturer	accessdata.fda.gov
Cap, Device Disinfectant	QBP	2	Manufacturer	accessdata.fda.gov
Central Venous Catheter Dressing Change Kit	PEZ	2	Manufacturer	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Manufacturer	accessdata.fda.gov
Digital Physical/Chemical Sterilization Process Sensor	SBE	2	Manufacturer	accessdata.fda.gov
Drape, Surgical, Antimicrobial	KKX	2	Manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Manufacturer	accessdata.fda.gov
Drape, Urological, Disposable	EYY	2	Manufacturer	accessdata.fda.gov
Dressing, Compression	MHW	1	Contract manufacturer	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Indicator, Biological Sterilization Process	FRC	2	Manufacturer	accessdata.fda.gov
Indicator, Physical/Chemical Sterilization Process	JOJ	2	Manufacturer	accessdata.fda.gov
Media, Electroconductive	GYB	2	Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Manufacturer	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Manufacturer	accessdata.fda.gov
Ring (Wound Protector), Drape Retention, Internal	KGW	2	Manufacturer	accessdata.fda.gov
Securement Wound Dressing For Reduction Of Infection	SEL	U	Manufacturer	accessdata.fda.gov
Staple, Removable (Skin)	GDT	1	Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 10, 2025	K251866	Tegaderm Post-Op Transparent Antimicrobial Dressing	FRO	Substantially Equivalent	Solventum US, LLC	accessdata.fda.gov
November 25, 2024	K242538	3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
October 18, 2024	K241959	3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M)	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
September 12, 2024	K241710	3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
June 27, 2024	K241542	3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
May 21, 2024	DEN230068	3M Attest eBowie-Dick Test Card 10135 3M Attest eBowie-Dick Card Holder 10135CH 3M Attest eBowie-Dick Auto-reader 1190	SBE	Unknown	3M Company	accessdata.fda.gov
May 18, 2023	K222578	3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)	KKX	Substantially Equivalent	3M Company	accessdata.fda.gov
September 23, 2022	K222152	3M Attest Hydrogen Peroxide Indicator Tape 1228	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
June 28, 2022	K211705	3M Attest Rapid Readout Biological Indicator, 1295	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
April 20, 2022	K212022	3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E	QKM	Substantially Equivalent	3M Company	accessdata.fda.gov
September 5, 2021	K212081	3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
October 29, 2020	K200299	Curos Jet Disinfecting Cap	QBP	Substantially Equivalent	3M Company	accessdata.fda.gov
September 4, 2020	K200835	3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad	FRO	Substantially Equivalent	3M Company	accessdata.fda.gov
April 15, 2020	K200092	3MTM AttestTM Mini Auto-reader 490M	FRC	Substantially Equivalent	3M	accessdata.fda.gov
January 22, 2018	K173584	3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
November 21, 2017	K170754	3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing	FRO	Substantially Equivalent	3M Company, 3M Healthcare	accessdata.fda.gov
July 11, 2017	K171908	3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing	SEL	Substantially Equivalent	3M Company	accessdata.fda.gov
December 4, 2014	K140657	CUROS RED PORT PROTECTOR	QBP	Substantially Equivalent	Ivera Medical, Inc.	accessdata.fda.gov
March 18, 2013	K123546	3M ATTEST(TM) AUTO-READER	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
February 28, 2013	K123679	3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING	FRO	Substantially Equivalent	3M Company	accessdata.fda.gov
November 26, 2012	K121171	CUROS TIP	QBP	Substantially Equivalent	Ivera Medical, Inc.	accessdata.fda.gov
January 12, 2012	K111992	CUROS PORT PROTECTOR	QBP	Substantially Equivalent	Ivera Medical, Inc.	accessdata.fda.gov
April 29, 2009	K090569	MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
October 16, 2003	K031012	ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
February 5, 1996	K955103	3M NO STING BARRIER FILM	KMF	Substantially Equivalent	3M Medical Products Group	accessdata.fda.gov
July 3, 1990	K900771	ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
September 17, 1981	K801550	3M GERMICIDAL SURGICAL INCISE DRAPE	KKX	Substantially Equivalent	3M Company	accessdata.fda.gov

Compare with other makers

Updated October 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. 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.