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

HNO — Predicate Candidate Screening

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

90 daysmedian FDA review time

235 days90th percentile

83clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K173371	VisuMax Femtosecond Laser	Carl Zeiss Meditec, Inc.	2018-04-13	168	0
K172994	EPI K Console	Moria SA	2017-10-26	29	0
K072102	EPIVISION SL SYSTEM	Gebauer Medizintechnik GmbH	2009-01-16	535	0
K082043	CARRIAZO-PENDULAR MICROKERATOME	Schwind Eye-Tech-Solutions GmbH & Co. KG	2008-08-01	14	0
K062465	ZYOPTIX XP EPI SEPARATOR SYSTEM	Bausch & Lomb, Inc.	2006-09-06	13	1
K052891	HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM	Hawken Industries	2006-03-23	161	0
K051486	NORWOOD ABBEY CENTURION SES EPIKERATOME	Norwood Abbey , Ltd.	2005-07-06	30	0
K043183	EPI-K	Moria SA	2005-03-25	128	0
K043150	AMADEUS II EPIKERATOME	Sis Ltd., Surgical Instrument Systems	2005-01-31	77	0
K042083	MODIFICATION TO VISITOME 20-10 MICROKERATOME	Biovision AG	2004-11-16	105	0
K042810	CENTURION SES EPIKERATOME	Norwood Abbey , Ltd.	2004-10-28	16	0
K041110	MB 105 MILLENNIUM BLADES	Millennium Biomedical, Inc.	2004-10-13	168	0
K041206	EPITOME SYSTEM	Gebauer Medizintechnik GmbH	2004-09-15	131	0
K032910	CARRIAZO PENDULAR	Schwind Eye-Tech-Solutions GmbH & Co. KG	2004-08-30	343	0
K032836	M3 MICROKERATOME	Moria SA	2004-06-18	281	0
K033457	M2 COMPATIBLE MICROKERATOME BLADE	Micro Specialties, Inc.	2004-05-25	208	0
K033236	PRIZM KERATOME BLADE, MODEL MK8512M2	Surgin Surgical Instrumentation, Inc.	2004-03-26	172	0
K040204	ZYOPTIX XP MICROKERATOME	Bausch & Lomb, Inc.	2004-03-22	53	4
K033182	PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD	Surgin Surgical Instrumentation, Inc.	2004-01-30	121	0
K033293	MED-LOGICS, MODEL ML7090	Med-Logics, Inc.	2004-01-13	91	1
K032978	MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME	Ciba Vision Corporation	2003-10-20	26	0
K032297	DISPOSABLE N-PE MICKROKERATOME BLADES	Oasis Medical, Inc.	2003-08-26	32	0
K031735	CENTURION SES EPIKERATOME	Ciba Vision Corporation	2003-08-21	78	0
K030401	DISPOSABLE M2-PE MICROKERATOME BLADES	Oasis Medical, Inc.	2003-06-19	133	0
K030891	SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK	Surgistar, Inc.	2003-06-17	88	0
K020482	KERATOME BLADE 200200 & 600600	Micro Specialties, Inc.	2002-12-16	306	0
K022982	MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB	Med-Logics, Inc.	2002-11-15	67	0
K022716	MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB	Med-Logics, Inc.	2002-10-11	57	0
K022205	DISPOSABLE N-PE MICROKERATOME BLADES	Oasis Medical, Inc.	2002-10-03	90	0
K021640	HANSATOME EXCELLUS MICROKERATOME	Bausch & Lomb, Inc.	2002-06-19	30	0
K020079	BLADEWORKS MICROKERATOME BLADE, MODEL 7061	Blade Works, Inc.	2002-04-19	99	0
K014000	VISTITOME 20-10 MICROKERATOME	Biovision AG	2002-03-11	97	0
K011833	MB 103 MILLENNIUM BLADES	Millennium Biomedical, Inc.	2002-02-15	248	0
K020122	MB 102 MILLENNIUM BLADES	Millennium Biomedical, Inc.	2002-02-15	32	0
K013337	PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI	Surgin, Inc.	2001-12-13	65	0
K011195	PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORI	Surgin Surgical Instrumentation, Inc.	2001-11-06	201	0
K010872	ML BLADE, MODEL ML7030	Med-Logics, Inc.	2001-06-22	91	0
K010260	HANSATOME MICROKERATOME	Bausch & Lomb, Inc.	2001-04-27	88	0
K003820	DISPOSABLE CB-PE MICROKERATOME BLADES	Oasis Medical, Inc.	2001-03-08	87	0
K002515	MEDLOGICS ML 4000, MODEL 4000	Med-Logics, Inc.	2001-02-22	191	0
K003143	MILLENNIUM BLADES, MODEL MB101	Millennium Biomedical, Inc.	2000-12-11	62	0
K002849	PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND	Surgical Specialties Corp	2000-10-18	35	0
K001464	DISPOSABLE H-PE MICROKERATOME BLADES	Oasis	2000-10-02	145	0
K001176	DISPOSABLE MICROKERATOME BLADES-PE	Oasis Medical, Inc.	2000-09-21	163	0
K001806	REFRACTIVE SURGERY BLADES	Millennium Biomedical, Inc.	2000-09-12	89	0
K001144	ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS	Lasersight Technologies, Inc.	2000-05-05	25	0
K993225	BLADEWORKS MICROKERATOME BLADE	Blade Works, Inc.	2000-03-20	175	0
K993122	MSP M/K BLADE	Medical Sterile Products, Inc.	2000-03-16	178	0
K994015	ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL),	Surgin Surgical Instrumentation, Inc.	2000-03-15	110	0
K993190	ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGI	Surgical Instrument Systems (Sis), Ltd.	2000-02-10	140	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