# K200970: Self-Contained Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: True Indicating, LLC
- Decided: Dec 28, 2020 after 259 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K801109 (1980). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122024: Spsmedical Sporview 10 Steam Self Contained Biological Indicator, Spsmedical Supply Corp. (2013) Summary page 4.

## Indications for use
The True Indicating Self-Contained Biological Indicator is intended for monitoring the efficacy of saturated steam sterilization processes. The True Indicating Self-Contained Biological Indicator has a validated reduced incubation time of 10 hours and may be used in the following steam sterilization cycles: 121°C, 30 minutes (Gravity) 132°C, 4 minutes (Pre-Vacuum) 135°C, 3 minutes (Pre-Vacuum)

Source page: https://510kreport.com/device/K200970
Methodology: https://510kreport.com/methodology