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

FOG — Predicate Candidate Screening

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

39 daysmedian FDA review time

90 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K973128	OLYMPUS NA-10J-1 ASPIRATION NEEDLE	Olympus America, Inc.	1997-11-18	89
K962182	BURLEW INFANT HOOD	Promedic, Inc.	1996-07-15	39
K955482	SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION)	Advantage Medical Services, Inc.	1996-01-30	90
K830781	ENDO-GUARD	Jayco Pharmaceuticals	1983-03-31	20
K792144	DISPOSA-HOOD	Utah Medical Products, Inc.	1979-12-05	43
K791861	OXYGEN HOODS	Ann Arbor Plastics, Inc.	1979-10-04	10
K790860	RT-HOOD	Plastics Supplies & Products	1979-05-29	22
K780220	HOOD, INFANT OXYGEN	Shiley, Inc.	1978-04-10	59
K770754	DUODENOSCOPE, MOLEL TX-6	American Cystocope Makers, Inc.	1977-04-28	3

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