# K220942: 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)

- Pathway: 510(k) (Special)
- Applicant: 3M Company
- Decided: Jun 24, 2022 after 85 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K771080 (1977). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193254: 3M Attest Steam Chemical Integrator, 3M Company (2019) Summary page 6.

## Most influential descendants
- K261992: 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (2026), 0 descendants of its own

## Recalls of this device
- Apr 6, 2023 · Class II · Z-1610-2023: 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.
- Apr 6, 2023 · Class II · Z-1609-2023: 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.

## Indications for use
The 3M™ Attest™ Steam Chemical Integrators are designed to respond to all critical parameters over a specified range of steam sterilization cycles. The integrating indicator is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Cycle Type Temperature Exposure Time Gravity 250°F/121°C 30 minutes Gravity 270°F/132°C 3 minutes Gravity 270°F/132°C 4 minutes Gravity 270°F/132°C 10 minutes Gravity 270°F/132°C 15 minutes Gravity 270°F/132°C 25 minutes Gravity 275°F/135°C 3 minutes Gravity 275°F/135°C 10 minutes Dynamic Air Removal 250°F/121°C 30 minutes Dynamic Air Removal 270°F/132°C 4 minutes Dynamic Air Removal 270°F/132°C 5 minutes Dynamic Air Removal 270°F/132°C 6 minutes Dynamic Air Removal 270°F/132°C 7 minutes Dynamic Air Removal 270°F/132°C 8 minutes Dynamic Air Removal 270°F/132°C 9 minutes Dynamic Air Removal 270°F/132°C 10 minutes Dynamic Air Removal 273°F/134°C 3 minutes Dynamic Air Removal 273°F/134°C 4 minutes Dynamic Air Removal 275°F/135°C 3 minutes Minimum Stated Values for 3M™ Attest™ Steam Chemical Integrators as determined in a resistometer: 250°F/121°C 270°F/132°C 273°F/134°C 275°F/135°C 16.5 Minutes 2.0 Minutes 1.4 Minutes 1.2 Minutes

Source page: https://510kreport.com/device/K220942
Methodology: https://510kreport.com/methodology