Atlas FDA

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

Metrix Co. — Predicate Candidate Screening

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

281 daysmedian FDA review time
315 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K030888EVA EMPTY SOLUTION CONTAINERMetrix Co.2003-04-021216
K895922METRICARE EMPTY CONTAINER SYSTEMSMetrix Co.1990-08-223150
K895924METRICARE DRUG RESERVOIRSMetrix Co.1990-07-262880
K895923METRICARE ENTERAL FEEDING SYSTEMMetrix Co.1990-07-192810
K761201ECHO-CARDIOTRACE, AUTOMATICMetrix Co.1977-01-12370

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