# Genadyne Biotechnologies, Inc.

- Location (FDA's records): Hicksville, NY
- FDA decisions: 21 (2008–2026): 21 510(k) clearances
- Names in FDA's records: Genadyne Biotechnologies, Inc. (19); Genadyne Biotechnologies (2)
- Product codes: OMP (16), HGX (3), BZD (1), BTA (1)
- 510(k) review time since 2016: median 325 days, against 198 for FDA's reviews in the same codes and years (2 of 10 faster)
- Predicates its devices cite: 24 (12 its own); citations of its devices by later devices: 22 (12 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medela AG: 3 (https://510kreport.com/company/medela)
- Smith & Nephew Medical Limited: 2 (https://510kreport.com/company/smith-nephew-medical)
- Convatec Limited: 1 (https://510kreport.com/company/convatec)
- Hsiner Co., Ltd.: 1 (https://510kreport.com/company/hsiner)
- Molnlycke Health Care Us, LLC: 1 (https://510kreport.com/company/molnlycke-health-care-us)
- Penumbra, Inc.: 1 (https://510kreport.com/company/penumbra)
- Blue Sky Medical Group Incorporated: 1 (https://510kreport.com/company/blue-sky-medical-group)
- Kci USA, Inc. (Kinetic Concepts, Inc.): 1 (https://510kreport.com/company/kci-usa-kinetic-concepts)

## Firms that cite its devices most
- Cork Medical Products, LLC: 2 (https://510kreport.com/company/cork-medical-products)
- Creo Quality, LLC: 2 (https://510kreport.com/company/creo-quality)
- Medela AG: 1 (https://510kreport.com/company/medela)
- Polynovo Biomaterials Pty, Ltd.: 1 (https://510kreport.com/company/polynovo-biomaterials)
- Baymax Research, Inc.: 1 (https://510kreport.com/company/baymax-research)
- Blue Ocean Medical Product, LLC: 1 (https://510kreport.com/company/blue-ocean-medical-product)
- Kevo Medical Supplies: 1 (https://510kreport.com/company/kevo-medical-supplies)
- Devon Medical, Inc.: 1 (https://510kreport.com/company/devon-medical)

## Its most-cited devices
- K092992: A4-XLR8 Foam Dressing (2010), cited by 8
- K082676: Genadyne A4 Wound Vacuum System (2008), cited by 3
- K210107: Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System (2022), cited by 2
- K102516: Lucina Model Melodi (2011), cited by 2
- K180840: UNO Negative Pressure Wound Therapy System (2018), cited by 2
- K090638: Genadyne A4-XLR8 Wound Vacuum System (2009), cited by 2

## Recent decisions
- K253429: Genadyne ASTRA NPWT (Mar 12, 2026)
- 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) (Dec 31, 2024)
- K233614: Genadyne DUO NPWT (Dec 23, 2024)
- K221888: Genadyne Hybrid Foam Dressings (Jun 12, 2023)
- K221891: UNO Negative Pressure Wound Therapy System (Dec 14, 2022)
- K210107: Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System (Jun 1, 2022)
- K190028: UNO 30 (Jan 15, 2020)
- K182722: XLR8 Abdominal Wound Dressing Kit (Sep 27, 2019)

Source page: https://510kreport.com/company/genadyne-biotechnologies