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

Leonard Medical, Inc. — Predicate Candidate Screening

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

37 daysmedian FDA review time

169 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K951854	LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY	Leonard Medical, Inc.	1995-06-21	61
K903536	SMALL JOINT INSTRUMENTS (SCISSOR HANDLE)	Leonard Medical, Inc.	1990-09-06	30
K895685	SMALL JOINT HAND INSTRUMENTS	Leonard Medical, Inc.	1989-10-16	24
K884308	MANDIBLE MANIPULATOR	Leonard Medical, Inc.	1989-03-31	169
K884314	LEONARD MEDICAL 1.7MM ARTHROSCOPE	Leonard Medical, Inc.	1989-03-13	151
K873139	VARUS AND VALGUS LEG HOLDER	Leonard Medical, Inc.	1987-09-16	37
K864117	SUPPORT ARM	Leonard Medical, Inc.	1986-11-03	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