# K242538: 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge  Pack  1493PCDG; 3M™ Attest™ Auto-reader  490; 3M™ Attest™ Auto-reader  490H; 3M™ Attest™ Mini Auto-reader  490M

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Nov 25, 2024 after 91 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: 7 generations back to K926364 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213809: 3M Attest  Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader, 3M Company (2022) Summary page 7.

## Indications for use
3M™ Attest™ Super Rapid Readout Biological Indicator 1493: Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1493 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles: Cycle Type — Exposure Temperature — Exposure Time Gravity Displacement — 250°F (121°C) — 30 minutes Dynamic-air-removal (pre-vacuum and SFPP) — 250°F (121°C) — 15, 20, 30, or 35 minutes 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG: Use the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles: Cycle Type — Exposure Temperature — Exposure Time Gravity Displacement — 250°F (121°C) — 30 minutes 3M™ Attest™ Auto reader 490: The 3M™ Attest™ Auto reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493 at 60°C for a final fluorescent result at 24 minutes. 3M™ Attest™ Auto-reader 490H: The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493 at 60°C for a final fluorescent result at 24 minutes. 3M™ Attest™ Mini Auto-reader 490M: The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1493, at 60°C for a final fluorescent result at 24 minutes.

Source page: https://510kreport.com/device/K242538
Methodology: https://510kreport.com/methodology