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510(k) K182458

Longterm NPWT Foam Dressing Kit by Zhejiang Longterm Medical Technology Co., Ltd. — Product Code OMP

K182458 is an FDA 510(k) premarket notification submitted by Zhejiang Longterm Medical Technology Co., Ltd. for the device "Longterm NPWT Foam Dressing Kit". The FDA issued a decision of Substantially Equivalent on May 23, 2019. The device falls under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump), a Class II device regulated under 21 CFR 878.4780. Zhejiang Longterm Medical Technology Co., Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2019
Date Received
September 10, 2018
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

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 Zhejiang Longterm Medical Technology Co., Ltd.

  • K254246 — LT Antibacterial Foam with Silver Dressing (September 10, 2026)
  • K211571 — Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit (May 31, 2022)
  • K202823 — Innomed NPWT Silicone Foam Dressing (December 15, 2021)
  • K192478 — LT Antibacterial Alginate with Silver Dressing (June 17, 2020)

Other clearances for product code OMP

  • K261338 — RENASYS DYNAFLOW Kit (66807741) (September 11, 2026)
  • 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)

FDA data resources