Birtcher Corp.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Birtcher Corp.” (first 1976, latest 1988), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 41 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 12 | 12 |
| DPS | Electrocardiograph | 6 | 6 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 2 | 2 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| DXJ | Display, Cathode-Ray Tube, Medical | 1 | 1 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 1 | 1 |
| LOS | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Birtcher Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K881328 | MODEL 375 ECG | DPS | 1988-05-18 | 50 |
| K860718 | ELECTROSURGERY PENCIL, MODEL 767 | GEI | 1986-03-24 | 26 |
| K860687 | BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768 | GEI | 1986-03-24 | 27 |
| K854814 | SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 33 | GEI | 1986-01-13 | 41 |
| K854864 | BI-POLAR FORCEPS | GEI | 1985-12-24 | 19 |
| K850943 | MODEL 775 BIPOLAR COAGULATOR | GEI | 1985-05-20 | 74 |
| K850668 | ELECTROSURGICAL UNIT 774 | GEI | 1985-05-20 | 89 |
| K844101 | CARDIO-NEC MODEL 365 | DPS | 1985-04-09 | 168 |
| K844104 | CARDIO ANALYZER MODEL 380 | LOS | 1985-03-06 | 134 |
| K850297 | ELECTROSURGICAL PENCIL HOLDER 720 | GEI | 1985-02-28 | 35 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Birtcher Corp..
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.
- Birtcher Medical Systems, Inc. (13 510(k)s)
- Birtcher Electro Medical Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Birtcher Corp.?
FDA lists 27 510(k) clearances under the applicant name “Birtcher Corp.” (first 1976, latest 1988), across 10 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 Birtcher Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Birtcher Corp. is 41 days.
Which FDA product codes appear under Birtcher Corp.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 12); DPS (Electrocardiograph, 6); IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat, 2).
Next steps
- See all 27 Birtcher Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Birtcher Corp.'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.