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

LRY · Predicate Candidate Screening

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

34 daysmedian FDA review time

247 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K933516	ACU-E PUNCH	Acuderm, Inc.	1994-03-24	247
K904869	ELLIPSE PUNCH	Kramer Const	1991-03-06	128
K902636	LIPOGEN RHEUMELISA DSDNA ASSAY	Lipogen, Inc.	1990-06-28	14
K896303	BIOPSY PUNCH	Premier Medical	1990-02-13	106
K874356	PIN PUNCH	Med-Tool, Inc.	1987-11-23	31
K874357	TAPERED PUNCH	Med-Tool, Inc.	1987-11-23	31
K872388	NAIL SET	Med-Tool, Inc.	1987-07-23	34

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