Genadyne Biotechnologies, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Genadyne Biotechnologies, Inc.” (first 2008, latest 2026), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 225 days. Since 2017 the median was 324 days, against 164 days for all cleared 510(k)s in the same product codes. 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 | 1 | 223 |
| 2013 | 0 | — |
| 2014 | 1 | 112 |
| 2015 | 4 | 198 |
| 2016 | 0 | — |
| 2017 | 1 | 301 |
| 2018 | 1 | 245 |
| 2019 | 1 | 364 |
| 2020 | 1 | 373 |
| 2021 | 0 | — |
| 2022 | 2 | 335 |
| 2023 | 1 | 348 |
| 2024 | 2 | 245 |
| 2025 | 0 | — |
| 2026 | 1 | 162 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Genadyne Biotechnologies, Inc. took a median 324 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 164 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 16 | 16 |
| HGX | Pump, Breast, Powered | 3 | 3 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
Review panels
Most recent Genadyne Biotechnologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253429 | Genadyne ASTRA NPWT | OMP | 2026-03-12 | 162 |
| K243225 | Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) | BZD | 2024-12-31 | 84 |
| K233614 | Genadyne DUO NPWT | OMP | 2024-12-23 | 406 |
| K221888 | Genadyne Hybrid Foam Dressings | OMP | 2023-06-12 | 348 |
| K221891 | UNO Negative Pressure Wound Therapy System | OMP | 2022-12-14 | 168 |
| K210107 | Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System | OMP | 2022-06-01 | 502 |
| K190028 | UNO 30 | OMP | 2020-01-15 | 373 |
| K182722 | XLR8 Abdominal Wound Dressing Kit | OMP | 2019-09-27 | 364 |
| K180840 | UNO Negative Pressure Wound Therapy System | OMP | 2018-11-30 | 245 |
| K161599 | UNO Negative Pressure Wound Therapy System | OMP | 2017-04-06 | 301 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Genadyne Biotechnologies, 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 Genadyne Biotechnologies, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Genadyne Biotechnologies, Inc.” (first 2008, latest 2026), 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 Genadyne Biotechnologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Genadyne Biotechnologies, Inc. is 225 days. Since 2017: 324 days, versus 164 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Genadyne Biotechnologies, Inc.?
The most frequent FDA product codes under this applicant name are OMP (Negative Pressure Wound Therapy Powered Suction Pump, 16); HGX (Pump, Breast, Powered, 3); BTA (Pump, Portable, Aspiration (Manual Or Powered), 1).
Next steps
- See all 21 Genadyne Biotechnologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OMP, Genadyne Biotechnologies, 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.