# K101528: 3M Comply Lead Free Process Indicators for Steam

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Oct 1, 2010 after 121 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K932129 (1994). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932129: 3M Autoclave Tapes, 3M Company (1994) Summary page 2.

## Most influential descendants
- K220564: 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355 (2022), 1 descendant of its own
- K181788: Lead-free Chemical Indicators for Steam Sterilization (2019), 1 descendant of its own
- K251991: SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) (2025), 0 descendants of its own
- K241836: Kem Medical Lead-free Chemical Indicators for Steam Sterilization (2024), 0 descendants of its own
- K220778: Chemical Indicator for Steam (2022), 0 descendants of its own

## Recalls of this device
- May 25, 2022 · Class III · Z-1794-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

## Indications for use
The 3M Comply Lead Free Process Indicators for Steam are designed to demonstrate that the unit or load has been exposed to a steam sterilization process and to distinguish between processed and unprocessed units or loads. 3M Comply Lead Free Process Indicators for Steam include: * Comply 68200 Lead Free Record Card * Comply 1322 Lead Free Indicator Tape * Lead Free Test Pack Labels to be used on test packs including the following - o Comply 41380 Steam-Plus Test Pack o Comply 41360 Steam Test Pack o Attest 1276 Steam Test Pack o Attest 1296 Steam Test Pack o Attest 41382 Steam-Plus Test Pack o Comply 1233LF, 00132LF, 00135LF Bowie Dick Test Packs Use the 3M Comply Lead Free Process Indicators for Steam in steam sterilization processes described below. Cycle Type — Temperature — Exposure Time Gravity — 250 °F/121 °C — > 30 minutes (wrapped) Gravity — 270 °F/132 °C — > 3 minutes (unwrapped); > 15 minutes (wrapped) Gravity — 275 °F/135 °C — > 3 minutes (unwrapped); > 11 minutes (wrapped) Vacuum-assisted (prevacuum) — 270 °F/132 °C — > 3 minutes (unwrapped); > 4 minutes (wrapped) Vacuum-assisted (prevacuum) — 273 °F/134 °C — > 3.5 minutes (unwrapped); 4 minutes (wrapped) Vacuum-assisted (prevacuum) — 275 °F/135 °C — > 3 minutes (wrapped or unwrapped)

Source page: https://510kreport.com/device/K101528
Methodology: https://510kreport.com/methodology