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

GBQ — Predicate Candidate Screening

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

39 daysmedian FDA review time

74 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K941356	MICROFLOW IRRIGATION SYSTEM	Jedmed Instrument Co.	1994-05-19	59
K921464	CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT	Trinity Laboratories, Inc.	1992-05-05	39
K882647	GESCO CATHETERIZATION TRAY	Gesco Intl., Inc.	1988-09-09	74
K874596	PERFORATED SOAKING TUBE	Specialty Medical Products Co.	1987-12-02	23
K873097	PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS	Ipax, Inc.	1987-09-04	39
K872787	MODIFIED CURLCATH	Quinton, Inc.	1987-08-04	22
K791400	GASTRIC LAVAGE KIT-DISPOSABLE	Acumed Instruments Corp.	1979-08-16	31
K771732	THORNTON ANTERIOR CHAMBER IRRIGATOR	Concept, Inc.	1977-09-28	13

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