# K121593: 3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest (TM) Super Rapid 5 Steam-Plus Challenge Pack

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Mar 15, 2013 after 288 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: 3 generations back to K926364 (1995). 7 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 19 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 1.
- K121484: 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM) Auto-Reader, 3M Company (2012). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K173519: 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader (2018), 7 descendants of its own
- K193154: 3M Attest Super Rapid 5 Steam-Plus Challenge Pack (2020), 3 descendants of its own
- K192550: 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H (2020), 2 descendants of its own
- K213809: 3M Attest  Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader (2022), 1 descendant of its own
- K170070: VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles (2017), 1 descendant of its own

## Indications for use
Use the 3M Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M Attest™ Super Rapid 5 Steam-Plus Steam Challenge Pack 41482V in conjunction with the 3M Attest™ Auto-reader 490 to qualify or monitor dynamic-air-removal (pre-vacuum) steam sterilization cycles of 270°F (132°C) at 4 minutes and 275°F (135°C) at 3 minutes. The 3M Attest™ Super Rapid Readout Biological Indicator 1492V contained in the challenge pack provides a final fluorescent result in 1 hour. An optional visual pH color change result is observed in 48 hours.

Source page: https://510kreport.com/device/K121593
Methodology: https://510kreport.com/methodology