# K991709: Browne Cidex Opa Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Albert Browne, Ltd.
- Decided: Oct 8, 1999 after 142 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 K922481 (1994). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
0 of 8 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.

## Most influential descendants
- K081370: Serim Disintek Opa Test Strip (2008), 2 descendants of its own
- K081427: Browne Opa Test Strip (2008), 2 descendants of its own
- K241344: MetriCide™ OPA Plus Solution Test Strip (2024), 0 descendants of its own
- K202565: WAVICIDE-OPA MEC Indicator (2020), 0 descendants of its own
- K181472: AEROFLEX (TM) Automatic Endoscope Reprocessor with AUTOSURE (TM) MRC Monitor (2019), 0 descendants of its own

## Recalls of this device
- Sep 4, 2003 · Not classified · Z-1481-04: Performance failure complaints.

## Indications for use
The Browne Cidex™ OPA Indicator is a concentration monitor for use in ortho- phthalalclehyde-containing germicide solutions with a minimum effective concentration of 0.3%. The Browne Cidex™ OPA Indicator is dedicated for use with Cidex™ OPA Solution.

Source page: https://510kreport.com/device/K991709
Methodology: https://510kreport.com/methodology