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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Philadelphia Medical Specialties · Predicate Candidate Screening

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

26 daysmedian FDA review time
86 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K840999PHILLY INFANT BOLTPhiladelphia Medical Specialties1984-04-04260
K834148PHILLY BOLTSPhiladelphia Medical Specialties1984-02-10860
K823459PHILLY BOLT ADULT PROCEDURE KITPhiladelphia Medical Specialties1982-12-22340
K822636CLASS II DEVICE FOR I.C.P. MONITORINGPhiladelphia Medical Specialties1982-09-14140
K820151PHILLY INFANT BOLTPhiladelphia Medical Specialties1982-01-2890
K813440PHILLY BOLTPhiladelphia Medical Specialties1981-12-18100

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