Atlas FDA

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

FOH — Predicate Candidate Screening

6 FDA 510(k) clearances under this product code; the 50 most recent screened below.

21 daysmedian FDA review time
93 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K954216OLYMPIC WARM-BASSINETOlympic Medical Corp.1995-12-08930
K872876IMSI/EASY FLOAT MATTRESSIntl. Management Services, Inc.1987-10-13840
K812683NEONATE FLEXFLOATPharmaquest Corp.1981-10-13210
K812682FLEXFLOAT HEATERPharmaquest Corp.1981-10-08160
K812681ADULT FLEX FLOAT W/HEATERPharmaquest Corp.1981-10-08160
K812684ADULT FLEXFLOATPharmaquest Corp.1981-10-08160

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