# K981054: Browne GA Indicator for Cidex Products

- Pathway: 510(k) (Traditional)
- Applicant: Albert Browne, Ltd.
- Decided: Dec 7, 1998 after 259 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
Longest line of descent: 1 generation back to K924681 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922481: Browne GA Indicator Use in 2% Activ Glutaraldehyde, Board of Directors, Albert Browne, Ltd. (1994) Summary page 1.
- K924681: Glutaraldehyde Monitors, Pymah Corp. (1993) Summary page 1.

## Most influential descendants
- K083295: Serim Disintek Gta 2.1%, Model: 5164 (2009), 0 descendants of its own

## Recalls of this device
- Mar 16, 2005 · Not classified · Z-0779-05: CIDEX test strips were found to pass solution below MEC.
- Sep 4, 2003 · Not classified · Z-1479-04: Performance failure complaints.
- Feb 14, 2003 · Not classified · Z-0695-03: Test strips which are used for QC of sterilant solution fail due to ingress of moisture.

## Indications for use
The Browne GA Indicator for Cidex Plus™ 28 Day Solution is a concentration monitor for use in glutaraldehyde-containing germicide solutions with a minimum effective concentration of 2.1%. The Browne GA Indicator for Cidex Plus™ 28 Day Solution is dedicated for use with Cidex Plus™ 28 Day Solution.

Source page: https://510kreport.com/device/K981054
Methodology: https://510kreport.com/methodology