510(k) Report

FDA applicant

Modern Medical Equipment Manufacturing Limited

Hong Kong, CN8 decisions2014–20220 recalls

FDA records 8 decisions for Modern Medical Equipment Manufacturing Limited (Hong Kong, CN) from 2014 to 2022: 8 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and HRX (Arthroscope). Since 2016 its 510(k)s took a median of 290 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Modern Medical Equipment Manufacturing, Ltd.”.

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 Modern Medical Equipment Manufacturing Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2014: 12016: 12017: 12018: 12020: 22021: 12022: 1
2014high 2 (2020) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Modern Medical Equipment Manufacturing Limited by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Modern Medical Equipment Manufacturing…’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 “Modern”

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