# K101249: Sterigage Model 1243RA, 1243RB, 1243RE

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Sep 8, 2010 after 127 days
- Product code: JOJ (Indicator, Physical/Chemical 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 K771080 (1977). 1 ancestor in all.
4 later devices descend 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)
- K771080: Steam Sterilization Indicator, Info-Chem (1977) Summary page 3.

## Most influential descendants
- K191236: 3M™ Attest™ Steam Chemical Integrators (2019), 3 descendants of its own
- K193254: 3M Attest Steam Chemical Integrator (2019), 2 descendants of its own
- K220942: 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) (2022), 1 descendant of its own
- K261992: 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (2026), 0 descendants of its own

## Indications for use
The 3M Comply SteriGage 1243RA, 1243RB, 1243RE Chemical Integrators for Steam are designed for pack control monitoring of the following cycles. Cycle Type: Gravity; Temperature: 250.0°F/121°C; Exposure Time: ≥30 minutes Cycle Type: Gravity; Temperature: 270°F/132°C; Exposure Time: ≥3 minutes Cycle Type: Vacuum-assisted (prevacuum); Temperature: 270°F/132°C; Exposure Time: >4 minutes (wrapped), >3 minutes (unwrapped) Cycle Type: Vacuum-assisted (prevacuum); Temperature: 273°F/134°C; Exposure Time: ≥4 minutes (wrapped), ≥3.5 minutes (unwrapped) Cycle Type: Vacuum-assisted (prevacuum); Temperature: 275°F/135°C; Exposure Time: ≥3 minutes The Minimum Stated Values for SteriGage as determined using a resistometer are shown below. Minimum Stated Values for SteriGage 250°F (121°C): 16.5 minutes 270°F (132°C): 2.0 minutes 273°F (134°C): 1.4 minutes 275°F (135°C): 1.1 minute

Source page: https://510kreport.com/device/K101249
Methodology: https://510kreport.com/methodology