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Data / Medical devices / Indicator, Biological Sterilization Process / United States

FDA-registered makers of Indicator, Biological Sterilization Process in the United States: 20 establishments

20 establishments in the United States are registered with the FDA to make Indicator, Biological Sterilization Process (product code FRC). 15 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
Indicator, Biological Sterilization Process
Product code
FRC
Country
United States

Makers of Indicator, Biological Sterilization Process in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Steris CorporationMentor, OH, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer34April 8, 2026000api.fda.gov
Solventum Us LLCEagan, MN, United StatesSpecification developer18November 25, 2024000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer18November 25, 2024000api.fda.gov
STERIS CorporationMentor, OH, United StatesManufacturer, Manufacturer for export, Repackager or relabeler14February 6, 2025000api.fda.gov
Solventum US LLCBrookings, SD, United StatesManufacturer11November 25, 2024000api.fda.gov
Crosstex InternationalRush, NY, United StatesManufacturer, Repackager or relabeler, Specification developer8August 7, 2014000api.fda.gov
Solventum US LLCFlemington, NJ, United StatesManufacturer8July 2, 2020000api.fda.gov
Mesa Laboratories Bozeman Manufacturing Facility (Zoot)Bozeman, MT, United StatesComplaint file establishment, Manufacturer7December 3, 2014030api.fda.gov
Advanced Sterilization ProductsIrvine, CA, United StatesComplaint file establishment, Manufacturer, Specification developer6January 23, 2020060api.fda.gov
Andersen Sterilizers, Inc.Haw River, NC, United StatesSpecification developer5April 12, 2022000api.fda.gov
STERIS CorporationFranklin Park, IL, United StatesComplaint file establishment, Manufacturer, Manufacturer for export5November 20, 2018000api.fda.gov
Propper MFG. Co., Inc.Long Island City, NY, United StatesManufacturer4May 23, 1996000api.fda.gov
Steritec Products MFG. Co., Inc.Englewood, CO, United StatesComplaint file establishment, Manufacturer4August 27, 2014010api.fda.gov
Mesa Laboratories, Inc.Denver, CO, United StatesComplaint file establishment, Manufacturer2March 26, 2013000api.fda.gov
True Indicating LLCToledo, OH, United StatesManufacturer1December 28, 2020000api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
Coast Pneumatics, Inc.Anaheim, CA, United StatesContract manufacturer0000api.fda.gov
Kem Medical Products Corp.Hauppauge, NY, United StatesContract manufacturer0000api.fda.gov
SNS Biosystems Inc.Santa Maria, CA, United StatesManufacturer0000api.fda.gov
Sanmina CorporationCarrollton, TX, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 2026. 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.