510(k) Report

FDA applicant

Berpu Medical Technology Co., Ltd.

Wenzhou, CN9 decisions2016–20240 recalls

FDA records 9 decisions for Berpu Medical Technology Co., Ltd. (Wenzhou, CN) from 2016 to 2024: 9 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and FMI (Needle, Hypodermic, Single Lumen). Since 2016 its 510(k)s took a median of 217 days from receipt to decision, against 200 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 3 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 Berpu Medical Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2016: 12018: 12019: 12022: 52024: 1
2016high 5 (2022) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Berpu Medical Technology Co., Ltd. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Berpu Medical Technology Co., Ltd.’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?

  • FMFSyringe, Piston4decisions
  • FMINeedle, Hypodermic, Single Lumen3decisions
  • MEGSyringe, Antistick2decisions

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 217 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 200 days; 2 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile…Berpu Medical Technology Co., Ltd. · 20188cite it
  • K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd. · 20163cite it
  • K181447Safety insulin needle for single useBerpu Medical Technology Co., Ltd. · 20193cite it
  • K213811Sterile Hypodermic Syringes for Single UseBerpu Medical Technology Co., Ltd. · 20221cites it
  • K220061Safety Insulin SyringesBerpu Medical Technology Co., Ltd. · 20221cites it

What has FDA decided for it lately?

  • K232165Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable…Berpu Medical Technology Co., Ltd. · 2024
  • K221045Insulin Syringes without needleBerpu Medical Technology Co., Ltd. · 2022
  • K220061Safety Insulin SyringesBerpu Medical Technology Co., Ltd. · 2022
  • K213158Syringe with permanently attached needleBerpu Medical Technology Co., Ltd. · 2022
  • K213811Sterile Hypodermic Syringes for Single UseBerpu Medical Technology Co., Ltd. · 2022
  • K212514Safety Pen Needle for Single Use, Insulin Pen NeedlesBerpu Medical Technology Co., Ltd. · 2022
  • K181447Safety insulin needle for single useBerpu Medical Technology Co., Ltd. · 2019
  • K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile…Berpu Medical Technology Co., Ltd. · 2018

All 9 as Berpu Medical Technology Co., Ltd. →