510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 1961 of 3531

510(k) clearances, page 1961 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K962342	Hemashield Finesse Ultra-Thin, Knitted Cardiovascular Patch	Meadox Medicals, Div. Boston Scientific Corp.	DXZ	Class II	1996-09-10
K962267	Perfecta Ps Revision Stem	Wrightmedicaltechnologyinc	JDI	Class II	1996-09-10
K962266	0.014 Inch Extra Long Floppy and 0.014 Extra Long Intermediate Guide Wires with Phosphorylcholine (Pc) Polymer Coating	Biocompatibles Cardiovascular, Inc.	DQX	Class II	1996-09-10
K962026	Prepowder Vinyl Patient Examination Gloves	Hong Huang Tang Industrial Co., Ltd.	LYZ	Class I	1996-09-10
K961625	Quatroloc Femoral Component & Head	Whiteside Biomechanics, Inc.	LPH	Class II	1996-09-10
K961420	Prostyle Compact	Planmeca Oy	EIA	Class I	1996-09-10
K961150	Dual Lumen Oxygen Delivery Gas Sampling Cannula	Hudson Respiratory Care, Inc.	CCK	Class II	1996-09-10
K960875	Kc 40 Micro Coagulation Analyzer System (K3632)	Sigma Diagnostics, Inc.	JPA	Class II	1996-09-10
K955628	Fore Runner External Defibrillator/defibrillator Pads	Heartstream, Inc.	MKJ	Class III	1996-09-10
K954350	Card Guard Model Cg-6500	Card Guard Scientific Survival, Ltd.	DXH	Class II	1996-09-10
K941782	Ventana Anti-Cd5 Primary Antibody	Ventana Medical Systems Inc	DEH	Class II	1996-09-10
K963346	Stabilyph Unassayed Ligand Assasy Control, Levels 1, 2 and 3	Consolidated Technologies, Inc.	JJY	Class I	1996-09-09
K963033	Bf 240/P240/it240 Bronchovideoscope & Accessories	OLYMPUS Corporation of the Americas	EOQ	Class II	1996-09-09
K962961	Sustained Phonation	Surface Mount Technology, Inc.	KTH	Class I	1996-09-09
K962798	Audio 'D' K-Amp Hr Full Shell and Canal Hearing Aids	Hearing Solutions, Inc.	ESD	Class I	1996-09-09
K962698	Acutek's Clearpasage	Acutek Adhesive Specialties, Inc.	LWF	Class I	1996-09-09
K962487	Breast Treatment Aid M200	S. and H. Engineering, Inc.	IYE	Class II	1996-09-09
K962469	Orgentec Anti-Cardiolipin Iga Elisa Assay	American Laboratory Products Company	MID	Class II	1996-09-09
K962400	Air Max External Nasal Dilator Strip	American White Cross, Inc.	LWF	Class I	1996-09-09
K962260	Real-Time Video Contrast Enhancer	Digivision, Inc.	LLZ	Class II	1996-09-09
K962118	Dsl Active Fsh Irma	Diagnostic Systems Laboratories, Inc.	CGJ	Class I	1996-09-09
K961023	Aidp(accuimage Image Display Processor)	Accuimage, Inc.	LMD	Class I	1996-09-09
K960715	Pruitt-Inahara Carotid Shunt 400-40-8F/inahara-Pruitt Carotid Shunt 500-50-8F	Ideas for Medicine, Inc.	MJN	Class II	1996-09-09
K955770	Gamma Glutamyl Transferase Test System	Abaxis Inc	JQB	Class I	1996-09-09
K953974	Camvision 1000	Medivision Medical Imaging, Ltd.	JAA	Class II	1996-09-09
K952882	Personal Telemedicine System	American Telecare, Inc.	DXN	Class II	1996-09-09
K963134	Drain/slit Sponge (Non-Sterile and Sterile)	Igenics, Inc.	EFQ	Unclassified	1996-09-06
K963122	Unitron Model Icon Kr	Unitron Industries, Inc.	ESD	Class I	1996-09-06
K962851	Acrynoodles Absorbent Wound Dressing	Acrymed, Inc.	MGQ	Unclassified	1996-09-06
K962741	Tri-Phasix Chromatic Alginate	Parkell, Inc.	ELW	Class II	1996-09-06
K962740	Dermistick Sepp Applicator(200 Ct)/(40 CT) 260640/260641	Medi-Flex Hospital Products, Inc.	KMF	Class I	1996-09-06
K962644	Vigor Compression Hip Screw System	Deutschland Surgical, Inc.	JDO	Class II	1996-09-06
K962614	Shifa Sterile Disposable Syringes	International Regulatory Consultants	FMF	Class II	1996-09-06
K962449	Osteo Compaction Kit	Steri-Oss, Inc.	DZE	Class II	1996-09-06
K962403	Noblepharma Wide Accessories	Nobelpharma USA, Inc.	DZE	Class II	1996-09-06
K961832	Blue Ridge Products Laryngoscope Blade Cover	Blue Ridge Medical, Inc.	CCW	Class I	1996-09-06
K961075	Medcare Regional Anethesia Kit	Medcare Medical Group, Inc.	CAZ	Class II	1996-09-06
K960457	Electronic Muscle Stimulator Model Ems-1C/ems-2C	Med Labs, Inc.	IPF	Class II	1996-09-06
K963154	Rionet Hb-54As	Authorized Hearing Systems, Inc.	ESD	Class I	1996-09-05
K963153	Rionet Hb-55S	Authorized Hearing Systems, Inc.	ESD	Class I	1996-09-05
K963152	Rionet Hb-55As	Authorized Hearing Systems, Inc.	ESD	Class I	1996-09-05
K962910	Spec t.e.n.s. Prewired Repositionable TENS Electrode - Modify	Uni-Patch, Inc.	GZJ	Class II	1996-09-05
K962711	Gelflex Alpha (Polymacon) Hydrophilic Contact Lens	Gelflex Laboratories	LPL	Class II	1996-09-05
K962710	Gelflex Delta 55 (Methafilcon a) Hydrophilic Contact Lens	Gelflex Laboratories	LPL	Class II	1996-09-05
K962499	Zymmune Autoreader-F Fluorescence Microplate Reader	Bartels, Inc.	JZT	Class I	1996-09-05
K962484	Synthes Titanium External Fixator Clamps (Ti Efc)	Synthes (USA) Products LLC	KTT	Class II	1996-09-05
K962361	Trachlight Stylet and Tracheal Lightwand	Laerdal Medical a/S	BSR	Class I	1996-09-05
K962300	Clampless Valved Catheter	Bmw Medical, Inc.	LJS	Class II	1996-09-05
K962275	Maico Ma25 Series II with Speech	Bernafon-Maico, Inc.	EWO	Class II	1996-09-05
K962237	Thumper Cardiopulmonary Resuscitator	Michigan Instruments	DRM	Class II	1996-09-05