# K922481: Browne GA Indicator Use in 2% Activ Glutaraldehyde

- Pathway: 510(k) (Traditional)
- Applicant: Board of Directors, Albert Browne, Ltd.
- Decided: Jun 2, 1994 after 737 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 5 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K012335: Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide Plus 30 Solutions (2001), 10 descendants of its own
- K081600: Steris Resert XL Test Strip (2008), 8 descendants of its own
- K991709: Browne Cidex Opa Indicator (1999), 6 descendants of its own
- K102217: System 1E Chemical Indicator (2010), 5 descendants of its own
- K173428: VERIFY Chemical Indicator for S40 Sterilant (2018), 3 descendants of its own

## Recalls of this device
- Sep 4, 2003 · Not classified · Z-1480-04: Performance failure complaints.
- Feb 25, 2003 · Not classified · Z-0712-03: Moisture ingress into packaging of test strips may cause premature failure.
- Feb 14, 2003 · Not classified · Z-0694-03: Test strips which are used for QC of sterilant solution fail prematurely due to ingress of moisture.

Source page: https://510kreport.com/device/K922481
Methodology: https://510kreport.com/methodology