Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

FNY — Predicate Candidate Screening

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

61 daysmedian FDA review time
248 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K832826AAP DOSIMETRY RELEASE OR BASIN SETSAmerican Hospital Supply Corp.1984-04-232480
K802538BASIN PACKTexas Medical Products, Inc.1980-10-31160
K800440STERILE SPONGE BOWLSPremium Plastics, Inc.1980-04-29610
K792625STERILIZATION PROCESS/PLACENTA BASINProcter & Gamble Mfg. Co.1980-01-16280
K7717338 EMESIS BASINBemis Health Care1977-09-28130
K760495BASIN, RECTANGULAR WASHLandmark Plastics1976-11-12810
K760494BASIN, ROUND WASHLandmark Plastics1976-11-12810
K760492BASIN, LARGE OR SMALLLandmark Plastics1976-11-12810
K760085BASIN, STERILE (#3200)Concord Laboratories, Inc.1976-07-20290

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