Burke Neutech, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Burke Neutech, Inc.” (first 1993, latest 1996), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 164 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 |
|---|---|---|---|
| ILO | Pack, Hot Or Cold, Water Circulating | 4 | 4 |
| GWY | Pinwheel | 1 | 1 |
| JFA | Exerciser, Finger, Powered | 1 | 1 |
| KCX | Epilator, High Frequency, Tweezer-Type | 1 | 1 |
Review panels
Most recent Burke Neutech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955326 | SPORTS CONTRAST THERAPY SYSTEM ST 7000 | ILO | 1996-04-10 | 142 |
| K952117 | EPILATOR | KCX | 1995-10-19 | 167 |
| K943497 | CONTRAST 7000 THERAPY SYSTEM | ILO | 1995-06-07 | 323 |
| K945803 | THERMAFLEX, MODEL SD 55 C.P.M.H. | JFA | 1995-05-11 | 164 |
| K942926 | NEURO-AIDE | GWY | 1994-08-03 | 42 |
| K940160 | TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM | ILO | 1994-05-27 | 135 |
| K926151 | LSI6000 THERMAL THERAPY SYSTEM | ILO | 1993-05-26 | 170 |
Recalls
openFDA lists no recalls under a recalling firm named Burke Neutech, 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, 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 Neutech, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Burke Neutech, Inc.” (first 1993, latest 1996), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Burke Neutech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Burke Neutech, Inc. is 164 days.
Which FDA product codes appear under Burke Neutech, Inc.?
The most frequent FDA product codes under this applicant name are ILO (Pack, Hot Or Cold, Water Circulating, 4); GWY (Pinwheel, 1); JFA (Exerciser, Finger, Powered, 1).
Next steps
- See all 7 Burke Neutech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ILO, Burke Neutech, 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.