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 2026-11-02, 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 983 of 3531

510(k) clearances, page 983 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K102893	Pcp/pc Stethoscope	Rnk Products, Inc.	DQD	Class II	2011-01-20
K102814	Elecysys Shbg	Roche Diagnostics GmbH	CDZ	Class I	2011-01-20
K102743	Ortho Solutions - Sterile, Drills, Taps, Guide Pins & Wires	Ortho Solutions Inc	HWE	Class I	2011-01-20
K102203	Chemtrue Single / Multi Drug Screen Cassette / Dip Card Tests	Chemtron Biotech, Inc.	DKZ	Class II	2011-01-20
K102153	Mobius Ultrasound Imaging System	Mobisante, Inc.	IYO	Class II	2011-01-20
K101446	Emerald Spinal System	Mazor Surgical Technologies, Ltd.	MNH	Class II	2011-01-20
K100610	Lutronic Corporation Eco2 Plus, Denta III and III+ and Sp III Laser Systems	Lutronic Corporation	ONG	Class II	2011-01-20
K100585	Medi-Therm Hyper/hypothermia System, Models Mta6900, Mta7900	Gaymar Industries, Inc.	DWJ	Class II	2011-01-20
K103710	Wbr Xpress Pet	Ultraspect, Ltd.	KPS	Class II	2011-01-19
K103533	Es Trochanteric Nail, Left and Right, 10Mm	Advanced Orthopaedic Solutions, Inc.	HSB	Class II	2011-01-19
K103250	Cps Direct Sl II Slittable Outer Catheter	St. Jude Medical, Cardiac Rhythm Management Divisi	DQY	Class II	2011-01-19
K103080	Albograft Vascular Prosthesis	LeMaitre Vascular Inc.	MAL	Class II	2011-01-19
K102594	Io-Flex Catheter	Baxano, Inc.	BSO	Class II	2011-01-19
K102370	R3 Xlpe Anteverted Liners	Smith & Nephew, Inc.	MBL	Class II	2011-01-19
K102195	Sp-Fix Spinous Process Fixation Plate	Globus Medical, Inc.	KWP	Class II	2011-01-19
K102165	Sterile Saline Solution	Cachet Pharmaceuticals Pvt., Ltd.	LPN	Class II	2011-01-19
K103469	Stockert Air Purge Control System Model 23-45-05	LivaNova Deutschland GmbH	KRL	Class II	2011-01-18
K103334	Cardio Med	Cardio Medical Products, Inc.	LDD	Class II	2011-01-18
K103133	Veper System, Expedium System	DePuy Spine, Inc.	NKB	Class II	2011-01-18
K102979	Nexgen Peripheral Guide Catheter	Nexgen Medical Systems, Inc.	DQY	Class II	2011-01-18
K101599	Rvt Cto Device	Revascular Therapeutics, Inc.	PDU	Class II	2011-01-18
K093627	Ipulselight Ipl System, Models Hs 300C and Hs 650	Shanghai Apolo Medical Technologies Co., Ltd.	ONF	Class II	2011-01-18
K083894	Alif Spinal Truss Interbody Fusion Device	4-Web Spine, LLC	MAX	Class II	2011-01-18
K103688	G-Prox Ez Endoscopic Grasper	Usgi Medical	OCZ	Class II	2011-01-14
K103501	Alma Lasers Pixel CO2 Laser System, Delivery Device and Accessories	Alma Lasers Ltd.	GEX	Class II	2011-01-14
K103353	Multipurpose Drainage Catheter; Nephrostomy Drainage Catheter; Biliary Drainage Catheter	Boston Scientific Corporation	FGE	Class II	2011-01-14
K103182	Triana, Picture Archiving and Communications System	Genoray Co., Ltd.	LLZ	Class II	2011-01-14
K103088	Given Pillcam Platform with Pillcam Sb Capsuleswith Pillcam R Sensorbelt	Given Imaging Ltd.	NEZ	Class II	2011-01-14
K103068	King Cobra Anterior Cervical Plate	Eminent Spine	KWQ	Class II	2011-01-14
K103032	Esg-400 Model Wb95051n, Footswitch Double Pedal Model Wb50402w, Footswitch Single Pedal Model Wb50403w, P-Cord Model Maj	Olympus Winter & Ibe GmbH	GEI	Class II	2011-01-14
K102959	Prolyte Electrolyte Analyzer	DIAMOND DIAGNOSTICS Inc	JGS	Class II	2011-01-14
K102934	Infrared Ear Thermometer, Model Ir-04Mt	Vega Technologies Inc.	FLL	Class II	2011-01-14
K102885	Hoffmann II External Fixation System Line Extension Model 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, Hoffmann II Ex	Stryker Corp.	JEC	Class II	2011-01-14
K102864	84E Series Single Ply Wrapper	Lac-Mac Limited	FRG	Class II	2011-01-14
K102857	Ahwon's Ipl System	Ahwon Medi Instrument Co., Ltd.	ONF	Class II	2011-01-14
K102601	Orthoflex Rod	Ortho-Pro, LLC	KWH	Class II	2011-01-14
K102589	Codman Bactiseal Catheters, Codman Bactiseal Evd Catheter	Cerenovus, Inc.	JXG	Class II	2011-01-14
K102584	Imc Hypodermic Needle	Intl. Medsurg Connection, Inc.	FMI	Class II	2011-01-14
K102432	Diazyme 25-Hydroxy Vitamin D Assay Kit Model Dz688a, Diazyme 25-Hydroxy Vitamin D Assay Calibrator Set Model Dz688a-Cal,	Diazyme Laboratories, Inc.	MRG	Class II	2011-01-14
K102385	Norfolk Medical Norport Family of Ports	Norfolk Medical Products, Inc.	LJT	Class II	2011-01-14
K102077	Modification to Cma Cerebral Tissue Monitoring System	Cma Microdialysis AB	GWM	Class II	2011-01-14
K101336	E1 Avantage Head	Biomet Manufacturing Corp	LPH	Class II	2011-01-14
K101216	Audit Microcv Protein Linearity Set	Aalto Scientific Ltd.	JJY	Class I	2011-01-14
K100829	Easyra Sodium Assay, Easyra Potassium Assay, Easyra Chloride Assay, Easyra Carbon Dioxide Assay Model Cat No. 5423 & 520	Medica Corp.	JGS	Class II	2011-01-14
K100649	Soundbite Hearing System by Sonitus	Sonitus Medical, Inc.	LXB	Class II	2011-01-14
K092963	Global Blastocyst Vitrification Kit & Vitrification Thawing Kit - Based on S3	<Genx> Intl., Inc.	MQL	Class II	2011-01-14
K103652	Suresigns Vm Series Patient Monitors, Suresigns Vm4, Suresigns Vm6, and Suresigns Vm8	Philips Medical Systesms	MHX	Class II	2011-01-13
K103232	Caspian Spinal System	K2M, Inc	KWP	Class II	2011-01-13
K102996	Medivators Advantage Plus Endoscope Reprocessor	Medivators Reprocessing Systems	FEB	Class II	2011-01-13
K102861	Surgiplus Sms Surgical Drape (Sterile/non-Sterile), Surgiplus Spp with Pe Laminated Surgical Drape (Sterile/non-Sterile)	A Plus International, Inc	KKX	Class II	2011-01-13