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

HMX — Predicate Candidate Screening

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

90 daysmedian FDA review time

133 days90th percentile

77clearances measured

K-number	Device	Applicant	Decided	Review days
K010305	WEISS RETINAL CANNULA	Micron Surgical, Inc.	2001-05-02	90
K000457	VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PH	Retinalabs.Com	2000-05-09	88
K970873	ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)	American Medical Devices, Inc.	1997-05-20	71
K943932	STERISEAL OPHTHALMIC CANNULA	Pharma-Plast, Ltd.	1995-01-18	159
K942403	INFUSION CANNULA	Microsurgical Technology, Inc.	1994-08-17	90
K934844	INTER TIP T	Microsurgical Technology, Inc.	1994-04-19	193
K930113	KIRWAN IRRIGATION/ASPIRATION HANDPIECE	Kirwan Surgical Products, Inc.	1994-02-17	402
K921488	ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION	Surgical Technologies, Inc.	1992-05-07	38
K915074	IRRIGATOR/ASPIRATOR PROBE	Biomedical Dynamics, Inc.	1992-02-05	89
K904074	VITREORETINAL INFUSION CANNULA	Visitec Co.	1991-02-26	175
K901618	OCULAR INFUSION CANNULA SYSTEM	Tamcenan Corp.	1990-05-31	55
K890782	GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES)	Grieshaber & Co.	1989-06-23	128
K882884	STORZ INFUSION CANNULA	Storz Instrument Co.	1988-08-04	24
K880346	CANNULAS	Myocure, Inc.	1988-05-03	98
K880347	ANESTHESIA/RETROBULBAR NEEDLES	Myocure, Inc.	1988-05-03	98
K875030	OCU-1	Rudolph Beaver, Inc.	1988-05-03	148
K881487	OPHTHALMIC CANNULA	Surgical Instrument, Inc.	1988-04-29	21
K874973	PRISMA DISPOSABLE SIMCOE I/A CANNULA	Advanced Surgical Products, Inc.	1988-04-13	133
K874981	PRISMA DISPOSABLE J-SHAPED I/A CANNULA	Advanced Surgical Products, Inc.	1988-04-13	133
K874974	PRISMA DISPOSABLE SIMCOE CAPSULE POLISHER	Advanced Surgical Products, Inc.	1988-04-13	133
K874994	PRISMA DISPOSABLE ANGLED I/A CANNULA	Advanced Surgical Products, Inc.	1988-04-13	133
K874972	PRISMA DISPOS. BISHOP-HARMON IRRIGATING CANNULA	Advanced Surgical Products, Inc.	1988-04-13	133
K874970	PRISMA DISPOS. TROUTMAN ALPHA-CHYMOTRYPSIN CANNULA	Advanced Surgical Products, Inc.	1988-04-13	133
K874996	PRISMA DISPOSABLE KUGLEN IRRIGATING LENS MANIPULA.	Advanced Surgical Products, Inc.	1988-04-13	133
K874995	PRISMA DISPOS. CURVED LACHRYMAL CANNULA	Advanced Surgical Products, Inc.	1988-04-13	133
K874980	PRISMA DISPOSABLE LEWICKY CHAMBER MAINTAINER	Advanced Surgical Products, Inc.	1988-04-13	133
K874989	PRISMA DISPOSABLE ADAPTER FOR IRRIGATORS	Advanced Surgical Products, Inc.	1988-04-13	133
K874977	PRISMA DISPOSABLE DOUBLE I/A CANNULA CLOSED	Advanced Surgical Products, Inc.	1988-04-13	133
K874987	PRISMA DISPOSABLE DOUBLE I/A CANNULA	Advanced Surgical Products, Inc.	1988-04-13	133
K875003	PRISMA DISPOSABLE PUPIL CENTERING CANNULA	Advanced Surgical Products, Inc.	1988-04-13	131
K874990	PRISMA DISPOSABLE SILICONE BULB	Advanced Surgical Products, Inc.	1988-04-13	133
K874982	PRISMA DISPOSABLE SIMCOE EXTRACTOR	Advanced Surgical Products, Inc.	1988-04-13	133
K874968	PRISMA DISPOSABLE GILLS ANGLED I/A CANNULA	Advanced Surgical Products, Inc.	1988-04-13	133
K874978	PRISMA DISPOSA. RYCROFT ANTERIOR CHAMBER CANNULA	Advanced Surgical Products, Inc.	1988-04-13	133
K874985	PRISMA DISPOSABLE CAPSULE POLISHER	Advanced Surgical Products, Inc.	1988-04-13	133
K874999	PRISMA DISPOSABLE ATKINSON RETROBULBAR NEEDLE	Advanced Surgical Products, Inc.	1988-04-13	133
K874984	PRISMA DISPOSABLE MICRO IRRIGATING VECTUS	Advanced Surgical Products, Inc.	1988-04-13	133
K874998	PRISMA DISPOSABLE U-SHAPED CANNULA	Advanced Surgical Products, Inc.	1988-04-13	133
K874971	PRISMA DISPOSABLE PEARCE IRRIGATING VECTUS	Advanced Surgical Products, Inc.	1988-04-13	133
K875002	PRISMA DISPOSABLE VISCOELASTIC I/A CANNULA	Advanced Surgical Products, Inc.	1988-04-13	131
K874988	PRISMA DISPOS. PEARCE IRRIGATING VECTUS W/ONE PORT	Advanced Surgical Products, Inc.	1988-04-13	133
K874986	PRISMA DISPOSABLE RETROBULBAR NEEDLE	Advanced Surgical Products, Inc.	1988-04-13	133
K874969	PRISMA DISPOSABLE KRATZ CAPSULE POLISHER	Advanced Surgical Products, Inc.	1988-04-13	133
K874992	PRISMA DISPOSABLE IRRIGATING LENS DIALER	Advanced Surgical Products, Inc.	1988-04-13	133
K873853	DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0	Advanced Surgical Products, Inc.	1988-03-07	167
K873162	VAN DELLEN RETROBULBAR NEEDLE	Van Dellen, Ltd.	1987-09-04	24
K873164	VAN DELLEN HEALON CANNULA	Van Dellen, Ltd.	1987-09-04	24
K872884	LOOK IRRIGATING/ASPIRATING CANNULA W/TEFLON SHEATH	Look, Inc.	1987-08-10	19
K872610	SOLOS EYESITE CANNULAS	Solos Ophthalmology	1987-07-31	25
K872200	HAMACHER BULLET POINT OPHTHALMIC NEEDLE	R. J. Doyle, Inc.	1987-06-25	17

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