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510(k) K213906

extriCARE 1000 Negative Pressure Wound Therapy System by Alleva Medical, Ltd. — Product Code OMP

K213906 is an FDA 510(k) premarket notification submitted by Alleva Medical, Ltd. for the device "extriCARE 1000 Negative Pressure Wound Therapy System". The FDA issued a decision of Substantially Equivalent on Mar 8, 2023. The device falls under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump), a Class II device regulated under 21 CFR 878.4780.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 8, 2023
Date Received
Dec 14, 2021
Clearance Type
Traditional
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
510(k)

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.

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  • 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 (Mar 12, 2026)
  • K250586 — Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White… (Nov 21, 2025)
  • K251646 — extriCARE® 1000 Negative Pressure Wound Therapy System (Oct 3, 2025)
  • K251826 — RENASYS WOUND+ Dressing Kit with AIRLOCK Technology (Sep 11, 2025)

FDA data resources