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

Microline Pentax, Inc. — Predicate Candidate Screening

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

70 daysmedian FDA review time

132 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K013695	MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLA	Microline Pentax, Inc.	2002-01-08	62	0
K982984	ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS	Microline Pentax, Inc.	1998-10-21	56	0
K981389	DISPOSABLE RE-NEW FORCEPS	Microline Pentax, Inc.	1998-05-29	43	5
K981188	ELECTROSURGICAL CAUTERY PROBES	Microline Pentax, Inc.	1998-05-20	48	0
K980758	3 MM SELEC-TIP LAPAROSCOPIC SCISSORS	Microline Pentax, Inc.	1998-03-27	28	0
K974066	RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS	Microline Pentax, Inc.	1998-01-22	87	0
K970826	SELECTA-TIP LAPAROSCOPIC SCISSORS	Microline Pentax, Inc.	1997-03-28	22	0
K962119	RE-NEW LAPAROSCOPIC INSTRUMENTS	Microline Pentax, Inc.	1996-08-09	70	0
K932648	QUICK SWITCH LAPAROSCOPIC INSTRUMENTS	Microline Pentax, Inc.	1993-10-12	132	0
K897093	INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA.	Microline Pentax, Inc.	1990-04-04	105	0
K881049	BRADBURY INTRAOCULAR RETINAL KIT CAT #200	Microline Pentax, Inc.	1988-09-12	185	0
K880943	MICROLINE CAT #100	Microline Pentax, Inc.	1988-05-26	80	0

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