Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Board of Directors, Albert Browne , Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
407 daysmedian FDA review time
737 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971971 | BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK | Board of Directors, Albert Browne , Ltd. | 1998-07-10 | 407 | 0 |
| K970918 | BROWNE STEAM INDICATOR | Board of Directors, Albert Browne , Ltd. | 1997-06-24 | 104 | 0 |
| K932057 | BROWNE TST SINGLE USE BOWIE DICK TYPE TEST PACK | Board of Directors, Albert Browne , Ltd. | 1994-08-05 | 464 | 0 |
| K922481 | BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE | Board of Directors, Albert Browne , Ltd. | 1994-06-02 | 737 | 3 |
| K902958 | TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE | Board of Directors, Albert Browne , Ltd. | 1990-11-01 | 119 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda