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510(k) K221891

UNO Negative Pressure Wound Therapy System by Genadyne Biotechnologies, Inc. — Product Code OMP

K221891 is an FDA 510(k) premarket notification submitted by Genadyne Biotechnologies, Inc. for the device "UNO Negative Pressure Wound Therapy System". The FDA issued a decision of Substantially Equivalent on December 14, 2022. The device falls under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump), a Class II device regulated under 21 CFR 878.4780. Genadyne Biotechnologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2022
Date Received
June 29, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

Other clearances by Genadyne Biotechnologies, Inc.

  • K253429 — Genadyne ASTRA NPWT (March 12, 2026)
  • K243225 — Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-0 (December 31, 2024)
  • K233614 — Genadyne DUO NPWT (December 23, 2024)
  • K221888 — Genadyne Hybrid Foam Dressings (June 12, 2023)
  • K210107 — Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System (June 1, 2022)
  • K190028 — UNO 30 (January 15, 2020)
  • K182722 — XLR8 Abdominal Wound Dressing Kit (September 27, 2019)
  • K180840 — UNO Negative Pressure Wound Therapy System (November 30, 2018)
  • K161599 — UNO Negative Pressure Wound Therapy System (April 6, 2017)
  • K143726 — XLR8 PLUS (XLR8+) (June 19, 2015)

Other clearances for product code OMP

  • K253263 — ConvaVAC™ Negative Pressure Wound Therapy System (June 24, 2026)
  • K253199 — CURASYS 2 (EMDN0003) (June 23, 2026)
  • K260646 — RENASYS EDGE (66803126) (May 27, 2026)
  • K261291 — Nisus NPWT Canister 500-mL (CPC-500) (May 21, 2026)
  • K254019 — Wound Geni NPWT System (May 4, 2026)
  • K253429 — Genadyne ASTRA NPWT (March 12, 2026)
  • K250586 — Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foa (November 21, 2025)
  • K251646 — extriCARE® 1000 Negative Pressure Wound Therapy System (October 3, 2025)
  • K251826 — RENASYS WOUND+ Dressing Kit with AIRLOCK Technology (September 11, 2025)
  • K243187 — Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) (June 27, 2025)

FDA data resources