FRCClass II

Indicator, Biological Sterilization Process

21 CFR 880.2800 / General Hospital

FRC is the FDA product code for Indicator, Biological Sterilization Process, a class II device type, regulated under 21 CFR 880.2800. As of 2026-09-10, FDA records hold 206 510(k) clearances under this code, the most recent dated 2026-04-08, and 40 recalls.

Classification record

Product code: FRC
Device name: Indicator, Biological Sterilization Process
Regulation: 21 CFR 880.2800
Device class: Class II
Review panel: General Hospital
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 206
Ingested recalls: 40

Clearances, product code FRC

By decision year

206 clearances under product code FRC with a decision year between 1977 and 2026, 2018 the highest year at 18.

Show the numbers

510(k) clearances under FDA product code FRC by decision year
Year	Clearances
1977	4
1980	6
1981	2
1982	1
1983	1
1984	2
1985	3
1986	5
1988	1
1989	6
1990	5
1991	1
1992	3
1993	1
1994	4
1995	1
1996	4
1997	4
1998	2
1999	1
2000	1
2001	2
2002	6
2003	4
2004	4
2005	7
2007	3
2008	1
2009	6
2010	4
2011	6
2012	9
2013	4
2014	13
2015	3
2016	2
2017	10
2018	18
2019	5
2020	10
2021	5
2022	5
2023	6
2024	8
2025	6
2026	1

Applicants with the most clearances

Product code FRC

Applicants holding the most 510(k) clearances under product code FRC
Applicant	Clearances
STERIS Corporation	35
3M Company	29
Advanced Sterilization Products	17
Raven Biological Laboratories, Inc.	12
Spsmedical Supply Corp.	9
Terragene LLC	6
Andersen Sterilizers, Inc.	5
Steritec Products Mfg. Co., Inc.	5
Surgicot, Inc.	5
Propper Mfg Co Inc	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 36 companies shown, in name order