Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Shenzhen Comen Medical Instruments Co.,Ltd · Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

283 daysmedian FDA review time
582 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250854Multi-parameter Patient Monitor (N10); Multi-parameter PatieShenzhen Comen Medical Instruments Co.,Ltd2025-12-172710
K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd2025-12-083190
K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd2022-12-295820
K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd2019-12-132320
K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd2018-08-162830

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda