# FRC: Indicator, Biological Sterilization Process

- Device class: 2; regulation: 21 CFR 880.2800; FDA's rule: 510(k) required
- FDA decisions: 206
- 510(k) review time 2021–2025: median 107 days (middle half 42–178)
- Recalls: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 10
- 2018: 18
- 2019: 5
- 2020: 10
- 2021: 5
- 2022: 5
- 2023: 6
- 2024: 8
- 2025: 6
- 2026: 1

## Most-cited predicates
- K191021: Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye (2019), cited by 6
- K994055: Sterrad Cyclesure Biological Indicator (2002), cited by 5
- K103277: 3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-Reader (2011), cited by 5
- K963841: Eztest (1997), cited by 5
- K071014: Modification to Sterrad Cyclesure Biological Indicator (2007), cited by 4
- K121484: 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM) Auto-Reader (2012), cited by 4
- K905425: Sporview (1992), cited by 4
- K031226: Sterrad Cyclesure Biological Indicator (2003), cited by 3
- K173437: 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H (2018), cited by 3
- K123017: Sterrad Cyclesure 24 Biological Indicator Model 14324 (2012), cited by 3

Source page: https://510kreport.com/product-code/FRC
Data by year (CSV): https://510kreport.com/product-code/FRC.csv