# K172472: Micro-MEC 1.8% Glutaraldehyde Monitor Strip

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Nov 17, 2017 after 94 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 K922481 (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)
- K012335: Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide Plus 30 Solutions, Albert Browne, Ltd. (2001) Summary page 5.

## Indications for use
The Micro-MEC 1.8% Glutaraldehyde Monitor Strip is a semi-quantitative chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in the solutions listed below, is greater than the minimum effective concentration (MEC) of 1.8% glutaraldehyde established for Micro-Cide™ 28 High Level Disinfectant (Micro-Cide™ 28 HLD)

Source page: https://510kreport.com/device/K172472
Methodology: https://510kreport.com/methodology