# K241836: Kem Medical Lead-free Chemical Indicators for Steam Sterilization

- Pathway: 510(k) (Traditional)
- Applicant: Kem Medical Products Corporation
- Decided: Sep 30, 2024 after 97 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: 2 generations back to K932129 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101528: 3M Comply Lead Free Process Indicators for Steam, 3M Company (2010) Summary page 5.

## Indications for use
The Kem Medical Lead-free Chemical Indicators for Steam Sterilization are designed for use by a health care provider 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. Use the Kem Medical Lead-free Chemical Indicators for Steam Sterilization in the validated steam sterilization processes described below: *Gravity: 121 C/250 F - 30 minutes (wrapped/porous) *Gravity: 132 C/270 F - 3 minutes (unwrapped/nonporous) *Gravity: 132 C/270 F - 15 minutes (wrapped/porous) *Gravity: 135 C/275 F - 3 minutes (unwrapped/nonporous) *Gravity: 135 C/275 F - 10 minutes (wrapped/porous or unwrapped/nonporous, mixed load) *Vacuum assisted (prevacuum): 132 C/270 F - 3 minutes (unwrapped/nonporous) *Vacuum assisted (prevacuum): 132 C/270 F - 4 minutes (wrapped/porous) *Vacuum assisted (prevacuum): 134 C/273 F - 4 minutes (wrapped/porous) *Vacuum assisted (prevacuum): 135 C/275 F - 3 minutes (wrapped/porous or unwrapped/nonporous, mixed load)

Source page: https://510kreport.com/device/K241836
Methodology: https://510kreport.com/methodology