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

JOK · Predicate Candidate Screening

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

56 daysmedian FDA review time

84 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K855131	SUTURE REMOVAL KIT	Dynarex Corp.	1986-01-13	21
K843075	UTILITY SCISSORS DISPOSABLE ITEMS	Greene International Corp.	1984-09-05	30
K812555	DISPOSABLE SUTURE REMOVAL SCISSORS	Medcare Products	1981-11-16	69
K770595	SUTURE REMOVAL SET	Abco Dealers, Inc.	1977-05-23	56
K770481	SHEAR, PLASTIC HANDLE UTILITY S-475-7	Acme United Corp.	1977-04-29	49
K770163	SUTURE CUTTER	Concept, Inc.	1977-03-30	64
K761192	DRESSING CHANGE KIT	Superior Plastic Products Corp.	1977-02-28	84

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