# K210481: Instant 20s Indicator

- Pathway: 510(k) (Traditional)
- Applicant: True Indicating, LLC
- Decided: Dec 14, 2021 after 298 days
- Product code: MTC (Indicator, Chemical, Enzymatic, 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: 1 generation back to K962649 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962649: Sportrol Rapid Sterility Indicator, North American Science Assoc., Inc. (1997) Summary page 4.

## Indications for use
The True Indicating Instant 20s Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring saturated steam sterilization processes operating at: 121 0 C, 30 minutes (Gravity) 132 0 C, 4 minutes (Pre-Vacuum) 135 0 C, 3 minutes (Pre-Vacuum)

Source page: https://510kreport.com/device/K210481
Methodology: https://510kreport.com/methodology