Atlas FDA

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

Procedure Packs, Inc. — Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K891572ANGIOGRAPHY CUSTOM PACKSProcedure Packs, Inc.1989-07-241260
K882717PROCEDURE PACKS CONTRAST MEDIA SETSProcedure Packs, Inc.1988-12-281800
K882655PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINEProcedure Packs, Inc.1988-09-16790
K882716PROCEDURE PACKS SOLUTION ADMINISTRATION SETSProcedure Packs, Inc.1988-09-16770

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