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

JYG — Predicate Candidate Screening

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

35 daysmedian FDA review time

95 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K932609	EAR CURETTE	Ear Tech, Inc.	1993-07-21	54
K852039	FLEX-LOOP FLEXIBLE EAR CORETTE	Bionix Corp.	1985-06-11	33
K841354	CURETTE	Treace Medical, Inc.	1984-07-06	95
K841001	EAR CURETTE, VARIOUS	Premier Dental Products Co.	1984-05-29	81
K823916	WAX CURETTE TIP	Treace Medical, Inc.	1983-01-21	24
K822273	ENT CURRETTES	Kelleher Corp.	1982-08-30	32
K822006	OPERATIVE EAR CURRETTES & RELATED ITEM	Kelleher Corp.	1982-08-12	35

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