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

HNQ — Predicate Candidate Screening

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

34 daysmedian FDA review time

133 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K030471	OPHTEC ENCLAVATION NEEDLE	Ophtec, USA	2003-04-17	64
K022842	STEPHENS DISPOSABLE HOOKS	Stephens Instruments	2002-11-01	66
K874991	PRISMA DISPOSABLE IRRIGATING IRIS HOOK	Advanced Surgical Products, Inc.	1988-04-13	133
K870440	LOOK LENS LOOPS	Look, Inc.	1987-02-20	17
K864292	DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY	Eye-Ko, Inc.	1986-12-29	59
K863988	THORTON TITANIUM HOOK ANGLED RIGHT	Keeler Instruments, Inc.	1986-10-31	17
K801469	BONN MICRO IRIS HOOK (NON-STERILE) #7613	Edward Weck, Inc.	1980-07-28	34
K791985	HOOKS #'S 7600,7602,7603,7616	Edward Weck, Inc.	1979-10-04	9
K770103	HOOK, IRIS, SHEPARD U-SHAPED	Edward Weck, Inc.	1977-01-25	8
K770098	HOOK, IRIS, HERSHMAN	Edward Weck, Inc.	1977-01-24	7

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