510(k) Report

FDA applicant

Lifetech Scientific (Shenzhen) Co., Ltd.

Shenzhen, CN3 decisions2010–20130 recalls

FDA records 3 decisions for Lifetech Scientific (Shenzhen) Co., Ltd. (Shenzhen, CN) from 2010 to 2013: 3 510(k) clearances. Most are in product codes MMX (Device, Percutaneous Retrieval) and DRE (Dilator, Vessel, For Percutaneous…). 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, cardiovascular panel, where it files most

How often FDA has decided Lifetech Scientific (Shenzhen) Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2010: 12011: 12013: 1
2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Lifetech Scientific (Shenzhen) Co., Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lifetech Scientific (Shenzhen) 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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Other applicant names beginning “Lifetech”

FDA records each applicant name separately; these may or may not be the same firm.