Atlas FDA

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

Pedia Pals, Inc. · Predicate Candidate Screening

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

188 daysmedian FDA review time
239 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K951041BLOOD PRESSURE CUFF 3Pedia Pals, Inc.1995-10-312390
K951040BLOOD PRESSURE CUFF 2Pedia Pals, Inc.1995-10-312390
K951039BLOOD PRESSURE CUFF 1Pedia Pals, Inc.1995-10-312390
K951050SPECULUM, ENT (S3)Pedia Pals, Inc.1995-04-17420
K951049SPECULUM, ENT (S3)Pedia Pals, Inc.1995-04-17420
K950086PEDIA PALS, INCORPORATEDPedia Pals, Inc.1995-02-07280
K911650PEDIA PALSPedia Pals, Inc.1991-10-171880

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