510(k) Report

FDA applicant

Board of Directors, Albert Browne, Ltd.

Leics. Le4 Oaa, GB5 decisions1990–19983 recalls

FDA records 5 decisions for Board of Directors, Albert Browne, Ltd. (Leics. Le4 Oaa, GB) from 1990 to 1998: 5 510(k) clearances. All are in product code JOJ (Indicator, Physical/Chemical Sterilization…). Its devices cite 1 predicate, 1 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Board of Directors, Albert Browne, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Board of Directors, Albert Browne, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Board of Directors, Albert Browne, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Board of Directors, Albert Browne, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • JOJIndicator, Physical/Chemical Sterilization Process5decisions

Who builds on its devices?

Later devices cite its devices 9 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K922481Browne GA Indicator Use in 2% Activ GlutaraldehydeBoard of Directors, Albert Browne, Ltd. · 19945cite it
  • K902958TST Control Integrator for Steam AutoclaveBoard of Directors, Albert Browne, Ltd. · 19903cite it
  • K932057Browne TST Single Use Bowie Dick Type Test PackBoard of Directors, Albert Browne, Ltd. · 19941cites it

What has FDA decided for it lately?

  • K971971Browne TST Single Use Bowie-Dick Type Test PackBoard of Directors, Albert Browne, Ltd. · 1998
  • K970918Browne Steam IndicatorBoard of Directors, Albert Browne, Ltd. · 1997
  • K932057Browne TST Single Use Bowie Dick Type Test PackBoard of Directors, Albert Browne, Ltd. · 1994
  • K922481Browne GA Indicator Use in 2% Activ GlutaraldehydeBoard of Directors, Albert Browne, Ltd. · 19943 recalls
  • K902958TST Control Integrator for Steam AutoclaveBoard of Directors, Albert Browne, Ltd. · 1990

All 5 as Board of Directors, Albert Browne, Ltd. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K922481Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX Products''Sep 4, 2003
  • K922481Gluteraldehyde Concentration Indicators. MetriTest 1.5% and MetriTest 1.8%, also…Feb 25, 2003
  • K922481Cidex Solution Test Strips Browne GA Indicators for Cidex Solution Test Strips.Feb 14, 2003