Atlas FDA

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

Vital Metrics, Inc. · Predicate Candidate Screening

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

61 daysmedian FDA review time
121 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K883201VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYSVital Metrics, Inc.1988-09-26600
K882956VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATIONVital Metrics, Inc.1988-08-03210
K844973IRRIGA SUC ILLUM ISIS 710 & 7100 SERIESVital Metrics, Inc.1985-03-18840
K843441URINARY DRAINAGE CONTAINER 2012-WITHVital Metrics, Inc.1985-01-031210
K843442URINARY DRAINAGE CONTAINER 2013 WITHVital Metrics, Inc.1985-01-031210
K840917URINARY MONITORING SYS 240Vital Metrics, Inc.1984-05-01610
K834448URINARY DRAINAGE CONTAINERVital Metrics, Inc.1984-02-10560
K832526UROTRACK PLUSVital Metrics, Inc.1983-09-19520
K813641VITAL METRICS URINE MONITORING SYSTEMVital Metrics, Inc.1982-03-01610

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