# K101910: 3M Attest Rapid Readout Steam Process Challenge Device, Model 1296V, 3M Attest Rapid Readout Steam-Plus

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Dec 8, 2010 after 152 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: 1 generation back to K925496 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925496: Ati Disposable Biological-Plus Test Pack, Pymah Corp. (1994) Summary page 3.
- (no number) 3M Attest Rapid Readout 1292 Biological Indicator: named in the summary without a submission number

## Most influential descendants
- K181434: SporView Rapid Read Biological Indicator SteamPlus Test Pack (2018), 0 descendants of its own

## Indications for use
Use the Attest 1296V Rapid Readout Steam and 41382V Rapid Readout Steam-Plus Process Challenge Devices to monitor 132 0 C (270'F) dynamic-air-removal (prevacuum) steam sterilization cycles with exposure time of 4 minutes.

Source page: https://510kreport.com/device/K101910
Methodology: https://510kreport.com/methodology