Bio Protech, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Bio Protech, Inc.” (first 2002, latest 2019), across 8 product codes in 5 review panels. Median 510(k) review time under this name: 82 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 | 1 | 108 |
| 2015 | 1 | 260 |
| 2016 | 2 | 198 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 30 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bio Protech, Inc. took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 121 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| GXY | Electrode, Cutaneous | 4 | 4 |
| FYD | Apparatus, Exhaust, Surgical | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| LIH | Interferential Current Therapy | 1 | 1 |
Review panels
- Neurology (7)
- Cardiovascular (4)
- General and Plastic Surgery (4)
- General Hospital (1)
- Physical Medicine (1)
Most recent Bio Protech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192035 | EvaQMax Smoke Evacuation System | FYD | 2019-08-29 | 30 |
| K152984 | Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes | IKT | 2016-06-03 | 238 |
| K153019 | Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes | GXY | 2016-03-21 | 158 |
| K143103 | PROPENCIL Smoke Pencil | GEI | 2015-07-16 | 260 |
| K142099 | CUTANEOUS ELECTRODES | GXY | 2014-11-17 | 108 |
| K111270 | REUSABLE STIMULATING ELECTRODES | GXY | 2011-09-13 | 133 |
| K100246 | MAX-IF1000 | LIH | 2010-11-24 | 301 |
| K091248 | MAXEMS, MODELS 1000 AND 2000 | IPF | 2009-11-30 | 216 |
| K092732 | PROPENCIL ESU PENCIL | GEI | 2009-11-25 | 82 |
| K092761 | PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C | GEI | 2009-11-24 | 76 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bio Protech, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bio Protech, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Bio Protech, Inc.” (first 2002, latest 2019), across 8 product codes in 5 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 Bio Protech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio Protech, Inc. is 82 days.
Which FDA product codes appear under Bio Protech, Inc.?
The most frequent FDA product codes under this applicant name are DRX (Electrode, Electrocardiograph, 4); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); GXY (Electrode, Cutaneous, 4).
Next steps
- See all 17 Bio Protech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRX, Bio Protech, 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.