510(k) Report

FDA applicant

Genadyne Biotechnologies, Inc.

Hicksville, NY21 decisions2008–20260 recalls

FDA records 21 decisions for Genadyne Biotechnologies, Inc. (Hicksville, NY) from 2008 to 2026: 21 510(k) clearances. Most are in product codes OMP (Negative Pressure Wound Therapy Powered…) and HGX (Pump, Breast, Powered). Since 2016 its 510(k)s took a median of 325 days from receipt to decision, against 198 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 12 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Genadyne Biotechnologies”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Genadyne Biotechnologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2008: 22009: 12010: 12011: 12012: 12014: 12015: 42017: 12018: 12019: 12020: 12022: 22023: 12024: 22026 (partial year): 1
2008high 4 (2015) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Genadyne Biotechnologies, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Genadyne Biotechnologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OMPNegative Pressure Wound Therapy Powered Suction Pump16decisions
  • HGXPump, Breast, Powered3decisions
  • BZDVentilator, Non-Continuous (Respirator)1decision
  • BTAPump, Portable, Aspiration (Manual Or Powered)1decision

How long do its 510(k) reviews take?

Since 2016, its 10 510(k)s took a median of 325 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 198 days; 2 of its 10 were faster than that.

Whose devices does it build on?

Its devices cite 24 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 times; 12 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K092992A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc. · 20108cite it
  • K082676Genadyne A4 Wound Vacuum SystemGenadyne Biotechnologies, Inc. · 20083cite it
  • K210107Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 20222cite it
  • K102516Lucina Model MelodiGenadyne Biotechnologies, Inc. · 20112cite it
  • K180840UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 20182cite it
  • K090638Genadyne A4-XLR8 Wound Vacuum SystemGenadyne Biotechnologies, Inc. · 20092cite it

What has FDA decided for it lately?

  • K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc. · 2026
  • K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow…Genadyne Biotechnologies, Inc. · 2024
  • K233614Genadyne DUO NPWTGenadyne Biotechnologies, Inc. · 2024
  • K221888Genadyne Hybrid Foam DressingsGenadyne Biotechnologies, Inc. · 2023
  • K221891UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2022
  • K210107Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2022
  • K190028UNO 30Genadyne Biotechnologies · 2020
  • K182722XLR8 Abdominal Wound Dressing KitGenadyne Biotechnologies · 2019

All 19 as Genadyne Biotechnologies, Inc. →All 2 as Genadyne Biotechnologies →