510(k) Report

FDA applicant

Zhejiang Longterm Medical Technology Co., Ltd.

Deqing, CN5 decisions2019–20260 recalls

FDA records 5 decisions for Zhejiang Longterm Medical Technology Co., Ltd. (Deqing, CN) from 2019 to 2026: 5 510(k) clearances. Most are in product codes OMP (Negative Pressure Wound Therapy Powered…) and FRO (Dressing, Wound, Drug). Since 2016 its 510(k)s took a median of 328 days from receipt to decision, against 234 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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 Zhejiang Longterm Medical Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2019: 12020: 12021: 12022: 12026 (partial year): 1
2019high 1 (2019) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Zhejiang Longterm Medical Technology Co., Ltd. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • OMPNegative Pressure Wound Therapy Powered Suction Pump3decisions
  • FRODressing, Wound, Drug1decision
  • NADDressing, Wound, Occlusive1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 328 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 234 days; 0 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd. · 2026
  • K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitZhejiang Longterm Medical Technology Co., Ltd. · 2022
  • K202823Innomed NPWT Silicone Foam DressingZhejiang Longterm Medical Technology Co., Ltd. · 2021
  • K192478LT Antibacterial Alginate with Silver DressingZhejiang Longterm Medical Technology Co., Ltd. · 2020
  • K182458Longterm NPWT Foam Dressing KitZhejiang Longterm Medical Technology Co., Ltd. · 2019

All 5 as Zhejiang Longterm Medical Technology Co., Ltd. →