Data / Medical devices / United States / Genadyne Biotechnologies, Inc.
Genadyne Biotechnologies, Inc.: FDA-registered device maker in Bohemia, NY, United States, 14 510(k) clearances
Genadyne Biotechnologies, Inc. is registered with the FDA (registration 3011582224) in Bohemia, NY, United States. It lists 5 device types. The FDA files 14 510(k) clearances under its listings, the newest dated March 12, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011582224
- Address
- 519 Johnson Ave, Bohemia, NY, United States, 11716
- Owner or operator
- GENADYNE BIOTECHNOLOGIES, INC. (9006819)
- Roles
- Manufacturer, Specification developer
- First device listed
- June 27, 2012
- Registered through
- 2026
- Brand names listed
- Algen, DUO, Gena Foam, Gentil Foam, Gentiltac, Nanogen Aktigel, Nanogen Aktiv, Nefes CPAP Nasal Pillow Mask and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Hydrophilic | NAC | 1 | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Manufacturer | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Manufacturer | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 12, 2026 | K253429 | Genadyne ASTRA NPWT | OMP | Substantially Equivalent | Genadyne Biotechnologies, Inc. | accessdata.fda.gov |
| December 31, 2024 | 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 | Substantially Equivalent | Genadyne Biotechnologies, Inc. | accessdata.fda.gov |
| December 23, 2024 | K233614 | Genadyne DUO NPWT | OMP | Substantially Equivalent | Genadyne Biotechnologies, Inc. | accessdata.fda.gov |
| June 12, 2023 | K221888 | Genadyne Hybrid Foam Dressings | OMP | Substantially Equivalent | Genadyne Biotechnologies, Inc. | accessdata.fda.gov |
| December 14, 2022 | K221891 | UNO Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | Genadyne Biotechnologies, Inc. | accessdata.fda.gov |
| June 1, 2022 | K210107 | Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | Genadyne Biotechnologies, Inc. | accessdata.fda.gov |
| January 15, 2020 | K190028 | UNO 30 | OMP | Substantially Equivalent | Genadyne Biotechnologies | accessdata.fda.gov |
| September 27, 2019 | K182722 | XLR8 Abdominal Wound Dressing Kit | OMP | Substantially Equivalent | Genadyne Biotechnologies | accessdata.fda.gov |
| November 30, 2018 | K180840 | UNO Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | Genadyne Biotechnologies, Inc. | accessdata.fda.gov |
| April 6, 2017 | K161599 | UNO Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | Genadyne Biotechnologies, Inc. | accessdata.fda.gov |
| April 30, 2015 | K142646 | XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and | OMP | Substantially Equivalent | Genadyne Biotechnologies, Inc. | accessdata.fda.gov |
| March 26, 2015 | K141961 | GENADYNE SPIRO FOAM DRESSING KIT | OMP | Substantially Equivalent | Genadyne Biotechnologies, Inc. | accessdata.fda.gov |
| July 16, 2012 | K120920 | HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA | BZD | Substantially Equivalent | Hsiner Company | accessdata.fda.gov |
| June 29, 2010 | K092992 | A4-XLR8 FOAM DRESSING | OMP | Substantially Equivalent | Genadyne Biotechnologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Negative Pressure Wound Therapy Powered Suction Pump
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Dressing, Wound, Occlusive
- All makers of Mesh, Surgical, Polymeric
- All makers of Dressing, Wound, Hydrophilic
Updated March 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.