Data / Medical devices / United States / Solventum US LLC

Solventum US LLC: FDA-registered device maker in Flemington, NJ, United States, 14 510(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 3036504234) in Flemington, NJ, United States. It lists 3 device types. The FDA files 14 510(k) clearances under its listings, the newest dated June 24, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3036504234
Address: 500 Rt. 202 North, Flemington, NJ, United States, 08822
Owner or operator: Solventum US LLC (10091183)
Roles: Manufacturer
First device listed: February 20, 1997
Registered through: 2026
Brand names listed: 3M¿ Attest¿ Auto-Reader

Devices it lists

Device	Product code	Class	Role	Source
Guard, Instrument	LXZ	1	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

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
June 24, 2022	K220942	3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
December 11, 2020	K203458	3M Comply Hydrogen Peroxide Chemical Indicator 1248	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
July 2, 2020	K200766	3M Attest Steam Chemical Integrator Test Pack	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
June 1, 2020	K200536	3MTM AttestTM Rapid 5 Steam-Plus Test Pack	FRC	Substantially Equivalent	3M Complany	accessdata.fda.gov
February 7, 2020	K193154	3M Attest Super Rapid 5 Steam-Plus Challenge Pack	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
April 23, 2018	K173519	3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
September 8, 2010	K101249	STERIGAGE MODEL 1243RA, 1243RB, 1243RE	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
December 4, 2009	K093199	3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK	JOJ	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
July 6, 1995	K952408	ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION	JOJ	Substantially Equivalent	Pymah Corp.	accessdata.fda.gov
February 1, 1994	K925496	ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK	FRC	Substantially Equivalent	Pymah Corp.	accessdata.fda.gov
November 1, 1985	K852192	DISPOSABLE STEAM BIOLOGICAL TEST PACK	FRC	Substantially Equivalent	Parke-Davis Co.	accessdata.fda.gov
December 31, 1981	K813202	THERMALOG S STEAM STERILIZATION INTEGRA	JOJ	Substantially Equivalent	Bio-Medical Sciences, Inc.	accessdata.fda.gov
July 14, 1977	K771080	STEAM STERILIZATION INDICATOR	FRC	Substantially Equivalent	Info-Chem	accessdata.fda.gov

Compare with other makers

Updated June 24, 2022. 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.