Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Albert Browne , Ltd. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
142 daysmedian FDA review time
410 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063285 | RELIANCE CI PROCESS INDICATOR | Albert Browne , Ltd. | 2007-01-12 | 73 | 0 |
| K061738 | ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD | Albert Browne , Ltd. | 2006-08-25 | 66 | 0 |
| K053479 | VERIFY DRY HEAT LABEL | Albert Browne , Ltd. | 2006-07-18 | 216 | 0 |
| K060066 | VERIFY 3-10 MIN FLASH INTEGRATOR | Albert Browne , Ltd. | 2006-03-24 | 74 | 0 |
| K060103 | ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS | Albert Browne , Ltd. | 2006-03-07 | 53 | 0 |
| K051101 | VERIFY FLASH INTEGRATOR | Albert Browne , Ltd. | 2005-12-06 | 221 | 0 |
| K051056 | VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR | Albert Browne , Ltd. | 2005-10-20 | 177 | 0 |
| K032801 | MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR | Albert Browne , Ltd. | 2003-10-17 | 38 | 0 |
| K002741 | BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK | Albert Browne , Ltd. | 2002-07-03 | 670 | 0 |
| K002937 | TST CONTROL INTEGRATOR FOR STEAM STERILIZERS | Albert Browne , Ltd. | 2001-11-05 | 410 | 0 |
| K012335 | BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 | Albert Browne , Ltd. | 2001-10-01 | 69 | 0 |
| K992767 | BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR | Albert Browne , Ltd. | 2000-01-10 | 146 | 0 |
| K991709 | BROWNE CIDEX OPA INDICATOR | Albert Browne , Ltd. | 1999-10-08 | 142 | 1 |
| K991418 | BROWNE MVI ETHYLENE OXIDE INDICATOR | Albert Browne , Ltd. | 1999-06-10 | 48 | 0 |
| K984613 | BROWNE SPORICIDIN PHENOL INDICATOR FOR SPORICIDIN STERILIZIN | Albert Browne , Ltd. | 1999-02-04 | 37 | 0 |
| K984616 | BROWNE SPORICIDIN GLUTARALDEHYDE INDICATOR FOR SPORICIDIN ST | Albert Browne , Ltd. | 1999-02-04 | 37 | 0 |
| K981054 | BROWNE GA INDICATOR FOR CIDEX PRODUCTS | Albert Browne , Ltd. | 1998-12-07 | 259 | 3 |
| K971369 | BROWNE MVI STEAM INDICATOR | Albert Browne , Ltd. | 1998-01-29 | 290 | 0 |
| K965154 | TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE | Albert Browne , Ltd. | 1997-09-19 | 270 | 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