510(k) Report

FDA applicant

Shanghai Carelife International Trading Co., Ltd.

Shanghai, CN2 decisions2014–20220 recalls

FDA records 2 decisions for Shanghai Carelife International Trading Co., Ltd. (Shanghai, CN) from 2014 to 2022: 2 510(k) clearances. Most are in product codes QRK (Single Use Only Blood Lancet Without An…) and FMI (Needle, Hypodermic, Single Lumen). Its devices cite 1 predicate, 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 Shanghai Carelife International Trading Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2014: 12022: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Shanghai Carelife International Trading Co., Ltd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shanghai Carelife International…’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?

  • QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature1decision
  • FMINeedle, Hypodermic, Single Lumen1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K221383MedtFine Blood LancetShanghai Carelife International Trading Co., Ltd. · 2022
  • K131954Medi Pen NeedleShanghai Carelife International Trading Co., Ltd. · 2014

All 2 as Shanghai Carelife International Trading Co., Ltd. →