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

GDI — Predicate Candidate Screening

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

43 daysmedian FDA review time

139 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K896383	DISPOSABLE EXTERNAL CLAMPS	Galenica Enterprises, Inc.	1989-12-06	30
K850288	HEPATIC PARENCHYMAL SUCTION DISSECTOR	Beecher Medical Diagnostic Instrumentation	1985-03-18	53
K831912	ROUND-BEEHIVE- DISSECTORS 3/8	Ormed Mfg., Inc.	1983-10-31	139
K822569	TYMPANOPLASTY & SKIN DISSECTORS	Kelleher Corp.	1982-10-06	43
K803292	FIELD SUCTION DISSECTOR	V. Mueller O.V. Baxter Healthcare Corp.	1981-01-29	30
K791870	DISPOSABLE SPECIALITY SPONGES	Carwild Corp.	1979-11-05	45
K791703	TEW BYPASS INSTRUMENTS & DISSECTING KIT	Edward Weck, Inc.	1979-10-04	37

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