510(k) Report

FDA applicant

Zhejiang Kindly Medical Devices Co., Ltd.

Wenzhou, CN5 decisions2018–20220 recalls

FDA records 5 decisions for Zhejiang Kindly Medical Devices Co., Ltd. (Wenzhou, CN) from 2018 to 2022: 5 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). Since 2016 its 510(k)s took a median of 177 days from receipt to decision, against 189 for FDA’s reviews in the same codes and years. Its devices cite 8 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 Zhejiang Kindly Medical Devices Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2018: 32022: 2
2018high 3 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Zhejiang Kindly Medical Devices Co., Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Zhejiang Kindly Medical Devices Co.…’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?

  • FMINeedle, Hypodermic, Single Lumen3decisions
  • BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)1decision
  • JKATubes, Vials, Systems, Serum Separators, Blood Collection1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 177 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 189 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 0 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.

  • K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood…Zhejiang Kindly Medical Devices Co., Ltd. · 20184cite it
  • K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia NeedlesZhejiang Kindly Medical Devices Co., Ltd. · 20182cite it
  • K181069Disposable Insulin Pen NeedleZhejiang Kindly Medical Devices Co., Ltd. · 20182cite it
  • K223334Sterile Hypodermic Needles for Single UseZhejiang Kindly Medical Devices Co., Ltd. · 20221cites it

What has FDA decided for it lately?

  • K223334Sterile Hypodermic Needles for Single UseZhejiang Kindly Medical Devices Co., Ltd. · 2022
  • K213183Safety Insulin Pen NeedlesZhejiang Kindly Medical Devices Co., Ltd. · 2022
  • K181069Disposable Insulin Pen NeedleZhejiang Kindly Medical Devices Co., Ltd. · 2018
  • K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood…Zhejiang Kindly Medical Devices Co., Ltd. · 2018
  • K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia NeedlesZhejiang Kindly Medical Devices Co., Ltd. · 2018

All 5 as Zhejiang Kindly Medical Devices Co., Ltd. →