Albert Browne , Ltd.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Albert Browne , Ltd.” (first 1997, latest 2007), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 142 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | 16 | 16 |
| LRT | Indicator, Sterilization | 2 | 2 |
| FRC | Indicator, Biological Sterilization Process | 1 | 1 |
Review panels
- General Hospital (19)
Most recent Albert Browne , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063285 | RELIANCE CI PROCESS INDICATOR | JOJ | 2007-01-12 | 73 |
| K061738 | ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD | JOJ | 2006-08-25 | 66 |
| K053479 | VERIFY DRY HEAT LABEL | JOJ | 2006-07-18 | 216 |
| K060066 | VERIFY 3-10 MIN FLASH INTEGRATOR | JOJ | 2006-03-24 | 74 |
| K060103 | ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS | JOJ | 2006-03-07 | 53 |
| K051101 | VERIFY FLASH INTEGRATOR | JOJ | 2005-12-06 | 221 |
| K051056 | VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR | FRC | 2005-10-20 | 177 |
| K032801 | MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR | JOJ | 2003-10-17 | 38 |
| K002741 | BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK | JOJ | 2002-07-03 | 670 |
| K002937 | TST CONTROL INTEGRATOR FOR STEAM STERILIZERS | LRT | 2001-11-05 | 410 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Albert Browne , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Albert Davydov Dds PC Professional (1 510(k)s)
- Albert J. Anthony, Dmd (1 510(k)s)
- Albert K. Chin (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Albert Browne , Ltd.?
FDA lists 19 510(k) clearances under the applicant name “Albert Browne , Ltd.” (first 1997, latest 2007), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Albert Browne , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Albert Browne , Ltd. is 142 days.
Which FDA product codes appear under Albert Browne , Ltd.?
The most frequent FDA product codes under this applicant name are JOJ (Indicator, Physical/Chemical Sterilization Process, 16); LRT (Indicator, Sterilization, 2); FRC (Indicator, Biological Sterilization Process, 1).
Next steps
- See all 19 Albert Browne , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JOJ, Albert Browne , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.