# K962649: Sportrol Rapid Sterility Indicator

- Pathway: 510(k) (Traditional)
- Applicant: North American Science Assoc., Inc.
- Decided: Sep 26, 1997 after 445 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K210481: Instant 20s Indicator (2021), 0 descendants of its own

## Indications for use
RSI Rapid Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring saturated steam sterilization processes operating at 121°C gravity, 132°C vacuum assisted 134°C vacuum assisted cycles.

Source page: https://510kreport.com/device/K962649
Methodology: https://510kreport.com/methodology