510(k) Report

FDA applicant

Jiangsu Kangbao Medical Equipment Co., Ltd.

Yangzhou, CN5 decisions2018–20230 recalls

FDA records 5 decisions for Jiangsu Kangbao Medical Equipment Co., Ltd. (Yangzhou, CN) from 2018 to 2023: 5 510(k) clearances. Most are in product codes MEG (Syringe, Antistick) and PNR (Enteral Syringes With Enteral Specific…). Since 2016 its 510(k)s took a median of 183 days from receipt to decision, against 189 for FDA’s reviews in the same codes and years. Its devices cite 6 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 Jiangsu Kangbao Medical Equipment Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2018: 12020: 12021: 12022: 12023: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

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

Planning a device like Jiangsu Kangbao Medical Equipment 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?

  • MEGSyringe, Antistick2decisions
  • PNREnteral Syringes With Enteral Specific Connectors1decision
  • JKATubes, Vials, Systems, Serum Separators, Blood Collection1decision
  • FPASet, Administration, Intravascular1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 183 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; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K211329Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable…Jiangsu Kangbao Medical Equipment Co., Ltd. · 20212cite it
  • K182649Enteral Feeding Syringes with Enfit ConnectorsJiangsu Kangbao Medical Equipment Co., Ltd. · 20181cites it
  • K221247Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable…Jiangsu Kangbao Medical Equipment Co., Ltd. · 20221cites it

What has FDA decided for it lately?

  • K232881Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2023
  • K221247Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2022
  • K211329Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2021
  • K192681Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2020
  • K182649Enteral Feeding Syringes with Enfit ConnectorsJiangsu Kangbao Medical Equipment Co., Ltd. · 2018

All 5 as Jiangsu Kangbao Medical Equipment Co., Ltd. →