Atlas FDA

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

Philadelphia Biologics Center · Predicate Candidate Screening

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

82 daysmedian FDA review time
96 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K841717INTRAVENOUS INJECTION SETPhiladelphia Biologics Center1984-07-23890
K834256PBC SYRINGE IRRIGATINGPhiladelphia Biologics Center1984-03-231070
K834255PBC SCALP VEIN SETPhiladelphia Biologics Center1984-03-12960
K834252PBC EXTENSION SETPhiladelphia Biologics Center1984-02-27820
K834253PBC IV SET NON-VENTEDPhiladelphia Biologics Center1984-02-27820
K834254PBC IV SET VENTEDPhiladelphia Biologics Center1984-02-27820
K820911PBC NEEDLE BY NIPRO MED. INDUSTRIESPhiladelphia Biologics Center1982-04-15140
K813646JMS DISPOSABLE SYRINGEPhiladelphia Biologics Center1982-01-28280
K813648JMS NEEDLE & MAC JECTPhiladelphia Biologics Center1982-01-28280
K813649PBC NEEDLEPhiladelphia Biologics Center1982-01-28280
K813647PBC SYRINGEPhiladelphia Biologics Center1982-01-25250

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