Atlas FDA

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

Procedure Products, Inc. — Predicate Candidate Screening

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

78 daysmedian FDA review time
269 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K161812Freedom SyringeProcedure Products, Inc.2017-03-272690
K923194INSUFFLATOR CONNECTING FILTERProcedure Products, Inc.1993-10-084650
K922536TORQUE DEVICEProcedure Products, Inc.1992-12-101960
K914128CONNECTING SETProcedure Products, Inc.1991-11-27750
K910673BAG SPIGOTProcedure Products, Inc.1991-04-24680
K884985MODIFIED 10CC SYRINGE CONTROL RING SETProcedure Products, Inc.1988-12-20190
K87474710CC SYRINGE CONTROL RING SETProcedure Products, Inc.1988-02-04780
K874037ANGIO WASTE FLUIDS DUMP BAGProcedure Products, Inc.1988-01-291160
K853749CUSTOM CORONARY MANIFOLD KITSProcedure Products, Inc.1986-01-131260
K842173DISPOSABLE STOPCOCKSProcedure Products, Inc.1984-09-051130
K833554MATERIAL ADDITION LEXAN & K-RESINProcedure Products, Inc.1984-03-121590
K820384GLASS SYRINGES, DRUG, LUER LOCKProcedure Products, Inc.1982-04-15650
K812657INJECTION CAP, LUER LOCKProcedure Products, Inc.1981-10-23350
K811548CERVICAL SPATULAProcedure Products, Inc.1981-06-23220
K810921MALE LUER LOCK PLUGSProcedure Products, Inc.1981-05-21450
K810859SINGLE USE SELDINGER/COURNAND PERC. NDLProcedure Products, Inc.1981-04-11121

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