Burke, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Burke, Inc.” (first 1984, latest 2006), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 40 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 |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | 3 | 3 |
| ILO | Pack, Hot Or Cold, Water Circulating | 2 | 2 |
| ITI | Wheelchair, Powered | 2 | 2 |
Review panels
Most recent Burke, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061912 | FUSION | INI | 2006-08-01 | 26 |
| K023961 | SCOUT BOSS | ITI | 2002-12-24 | 25 |
| K982158 | SCOUT | ITI | 1998-08-31 | 73 |
| K965123 | PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE) | INI | 1997-07-17 | 244 |
| K911943 | CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM | ILO | 1991-07-19 | 79 |
| K893706 | COLD/HOT FLUID RADIATION PAD NEUTECH | ILO | 1989-06-22 | 35 |
| K834506 | PACESAVER & SCOUT | INI | 1984-01-30 | 40 |
Recalls
openFDA lists no recalls under a recalling firm named Burke, Inc..
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.
- Burke Neutech, Inc. (7 510(k)s)
- Burke Mobility Products (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Burke, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Burke, Inc.” (first 1984, latest 2006), 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 Burke, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Burke, Inc. is 40 days.
Which FDA product codes appear under Burke, Inc.?
The most frequent FDA product codes under this applicant name are INI (Vehicle, Motorized 3-Wheeled, 3); ILO (Pack, Hot Or Cold, Water Circulating, 2); ITI (Wheelchair, Powered, 2).
Next steps
- See all 7 Burke, Inc. clearances with predicates and recalls
- Run predicate analysis for product code INI, Burke, Inc.'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.