Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

HNF — Predicate Candidate Screening

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

28 daysmedian FDA review time

88 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K022840	STEPHENS DISPOSABLE SCISSORS	Stephens Instruments	2002-11-01	66
K897093	INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA.	Microline Pentax, Inc.	1990-04-04	105
K873099	MANUAL OPHTHALMIC SURGICAL INSTRUMENTS	Alcon Laboratories	1987-09-04	28
K851768	13-550,13-560 WESCOTT SCOSSORS (EYE)	Artiberia	1985-06-20	56
K822151	SURGICAL INSTRUMENTS REPRESENT. 4 CLASS	Robert I. Chien & Assoc., Inc.	1982-08-19	28
K821290	LITTAUER SCISSORS 5 1/2	Conphar, Inc.	1982-05-28	24
K821286	IRIS SCISSORS STRAIGHT 4 1/2	Conphar, Inc.	1982-05-28	24
K811245	OPHTHALMIC SCISSORS	Keeler Instruments, Inc.	1981-07-31	88
K770040	SCISSORS, STRABIMUS, 4 STRAIGHT	J. Sklar Mfg. Co., Inc.	1977-01-14	4
K770041	SCISSORS, STRABISMUS, 4 CURVED	J. Sklar Mfg. Co., Inc.	1977-01-14	4
K770019	SCISSORS, IRIS	J. Sklar Mfg. Co., Inc.	1977-01-12	7
K760185	SCISSORS, MICRO IRIS STRAIGHT	V. Mueller O.V. Baxter Healthcare Corp.	1976-08-04	29
K760326	SURGICAL INSTRUMENTS, OPTHALMIC	Depuy, Inc.	1976-08-04	9
K760188	SCISSORS, MICRO IRIS CURVED	V. Mueller O.V. Baxter Healthcare Corp.	1976-08-04	29
K760190	SCISSORS, IRIS STRAIGHT	V. Mueller O.V. Baxter Healthcare Corp.	1976-08-04	29

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