Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

KGB — Predicate Candidate Screening

13 FDA 510(k) clearances under this product code; the 50 most recent screened below.

164 daysmedian FDA review time

214 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K970688	POCKET RESCUE	Cheen Houng Ent. Co. , Ltd.	1997-09-26	213
K960401	ULTIMATE SEAL	Hans Rudolph, Inc.	1996-06-20	143
K941336	COMBO MASK	Gam Industries, Inc.	1994-09-09	172
K935917	CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GL	Bd Becton Dickinson Vacutainer Systems Preanalytic	1994-02-04	56
K932347	COMPACT MASK	Vital Signs, Inc.	1994-01-10	241
K933583	NONREBREATHING VALVE	Hans Rudolph, Inc.	1994-01-03	164
K933048	LAERDAL(TM) POCKET MASK, MODIFICATION	Laerdal Medical Corp.	1993-12-02	205
K930336	PROFAST(R)-DENTURE ADHESIVE CREAM	Fittydent-Altwirth & Schmitt GmbH	1993-08-24	214
K913164	NON REBREATHING MASK	Specialty Packaging Producs, Inc.	1992-01-15	182
K883766	MOUTH-TO-MASK VENTILATORY ADJUNCT	Medic One	1988-10-21	45
K790162	OXYGEN MASK, CONCENTRATION AEROSOL MASK	Airlife, Inc.	1979-04-20	98
K790161	OXYGEN MASK W/RESERVOIR BAG	Airlife, Inc.	1979-04-20	98
K781414	MASK, OXYGEN, NONBREATHING	Vitalab Products Corp.	1978-09-07	23

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