510(k) Report

FDA applicant

Hantech Medical Device Co., Ltd.

Ningbo, CN5 decisions2022–20230 recalls

FDA records 5 decisions for Hantech Medical Device Co., Ltd. (Ningbo, CN) from 2022 to 2023: 5 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and FMF (Syringe, Piston). Since 2016 its 510(k)s took a median of 174 days from receipt to decision, against 142 for FDA’s reviews in the same codes and years. Its devices cite 5 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 hospital panel, where it files most

How often FDA has decided Hantech Medical Device Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2023

2022: 22023: 3
2022high 3 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Hantech Medical Device Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hantech Medical Device Co., Ltd.’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?

  • FMINeedle, Hypodermic, Single Lumen2decisions
  • FMFSyringe, Piston1decision
  • FXXMask, Surgical1decision
  • NGTSaline, Vascular Access Flush1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 174 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 142 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)Hantech Medical Device Co., Ltd. · 2023
  • K222739Disposable Insulin Pen NeedleHantech Medical Device Co., Ltd. · 2023
  • K222672Disposable Insulin SyringeHantech Medical Device Co., Ltd. · 2023
  • K221038Disposable Medical MasksHantech Medical Device Co., Ltd. · 2022
  • K220603Disposable Medical Safety Hypodermic NeedleHantech Medical Device Co., Ltd. · 2022

All 5 as Hantech Medical Device Co., Ltd. →