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 1402 of 3531

510(k) clearances, page 1402 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032717	Biocryl Rapide Interference Screw	Mitek Worldwide	HWC	Class II	2004-03-31
K040635	Carrara Interaction Ceramic System	Dentsply Intl.	EIH	Class II	2004-03-30
K040027	Boston Scientific Express Biliary Sd Premounted Stent System	Boston Scientific Corporation	FGE	Class II	2004-03-30
K034011	Gemini Surgical Laser System & Accessories	Laserscope	GEX	Class II	2004-03-30
K032143	Liquid Oxygen System	Micro Technology Services, Inc.	BYJ	Class II	2004-03-30
K040535	Linical Enzyme Calibration Verifiers Levels a-E for Beckman Coulter Synchron Systems	Cliniqa Corporation	JJY	Class I	2004-03-29
K040399	Qontrast	Amid	LLZ	Class II	2004-03-29
K040065	Jsa's Reprocessed Compression Sleeve Devices	Jack Speer and Assoc., Inc.	JOW	Class II	2004-03-29
K040041	Nio 3Mp Medical Grayscale Display System	Barco NV Barcoview	LLZ	Class II	2004-03-29
K040040	Nio 5Mp Medical Grayscale Display System	Barco NV Barcoview	LLZ	Class II	2004-03-29
K040005	Profile 2000/3000 Laser System	Sciton, Inc.	GEX	Class II	2004-03-29
K033986	Mlt-1000 Ir Laser System	Medical Laser Therapeutics LP	ILY	Class II	2004-03-29
K032445	The Ultra System	Promedica, Inc.	KCT	Class II	2004-03-29
K032227	Durex Flavored Latex Condom	Ssl Americas, Inc.	HIS	Class II	2004-03-29
K040719	Aloka Model Ssd-4000 Diagnostic Ultrasound System W/optional Sonoreal 3D System Accessory	Aloka Co., Ltd.	IYO	Class II	2004-03-26
K040527	Low Profile Luther Safety Huber	Luther Needlesafe Products LLC	FPA	Class II	2004-03-26
K040216	Cerasorb M Ortho	Curasan AG	MQV	Class II	2004-03-26
K040130	Anterior Lumbar Buttress System	Seaspine, Inc.	KWQ	Class II	2004-03-26
K040128	Modification to Modular Replacement System (Mrs) Humeral Stems	Howmedica Osteonics Corp	HSD	Class II	2004-03-26
K040003	Vertebron Scp Cervical Plate System	Vertebron, Inc.	KWQ	Class II	2004-03-26
K034068	Contour Se Microspheres	Boston Scientific Corporation	KRD	Class II	2004-03-26
K034025	Nmt Medical Transseptal Sheath Set, Models Tss-10-Hsc, Tss-11-Hsc, Tss12-Hsc	Nmt Medical, Inc.	DYB	Class II	2004-03-26
K033970	Clearfil Photo Core Plt	Kuraray Medical, Inc.	EBF	Class II	2004-03-26
K033460	Cheetah Wheelchair	R82 a/S	IOR	Class I	2004-03-26
K033236	Prizm Keratome Blade, Model Mk8512m2	Surgin Surgical Instrumentation, Inc.	HNO	Class I	2004-03-26
K033090	Icon Polyaxial Pedicle Screw System	Alphatec Spine, Inc.	KWP	Class II	2004-03-26
K033050	En Circlr Al Adjustable Loop Mapping Catheter Models, 1045Al1, 1045Al2, 1060Al1, 1060Al2	Medtronic, Inc.	DRF	Class II	2004-03-26
K032816	Quantum Light Therapy System	Stargate International, Inc.	NHN	Class II	2004-03-26
K032730	Fixion Hip System	Disc-O-Tech Medical Technologies, Ltd.	JDI	Class II	2004-03-26
K032386	Uni-Vent Model 730Aev (Automatic Emergency Ventilator)	ZOLL Medical Corporation	BTL	Class II	2004-03-26
K031421	Ultrasonic Scaler, Models Varios 350 Lux, Varios 350 (No Light), Varios 550, Varios 150 Lux, Varios 150 (No Light)	Nakanishi Inc.	ELC	Class II	2004-03-26
K023525	Retiscan, Retiport	Roland Consult	GWE	Class II	2004-03-26
K040694	Modification to Sapphire Detachable Coil System (Tetris 3-D)	Medtronic, Inc.	HCG	Class II	2004-03-25
K040670	Modification to Truetrack Smart System Blood Glucose Meter, Test Strips and Glucose Control	Home Diagnostics, Inc.	NBW	Class II	2004-03-25
K040628	Precision Link Diabetes Data Management System	Abbott Medical	NBW	Class II	2004-03-25
K040618	LED Turbo	Apoza Enterprise Co., Ltd.	EBZ	Class II	2004-03-25
K040609	Rapid Programmer	Abbott Medical	GZB	Class II	2004-03-25
K040568	Polyether Urethane Material Change in Neurostimulation Leads	Medtronic, Inc.	GZB	Class II	2004-03-25
K040517	Tenderwet Active	MEDLINE INDUSTRIES, LP - Northfield	MGQ	Unclassified	2004-03-25
K040226	Wako Auto Kit Prealbumin, Wako Autokit Prealbumin Calibrator Set, Prealbumin Control Set	FUJIFILM Healthcare Americas Corporation	JIT	Class II	2004-03-25
K040203	Monitect Mdma Drug Screen Cassette Test, Model Mc22; Fastect II Mdma Drug Screen Dipstick Test, Model Mf22	Branan Medical Corp.	DKZ	Class II	2004-03-25
K040109	Hemorrhage Occluder Pin	Tools for Surgery, LLC	GDW	Class II	2004-03-25
K040053	Precision Vps Impression Material	Discus Dental LLC	ELW	Class II	2004-03-25
K033994	Novabone-Bbg-Resorbable Bone Graft Substitute	Novabone Products, LLC	LYC	Class II	2004-03-25
K031176	Invacare Polaris Ex Heated Humidifier, Model Isp4000	Invacare GmbH	BTT	Class II	2004-03-25
K040616	Cardiomd-Ac	Danish Diagnostic Development A/S	KPS	Class II	2004-03-24
K040521	Modification to Ams Large Pore Polypropylene Mesh	American Medical Systems, Inc.	OTP	Class III	2004-03-24
K040398	Surgassist Straight Linear 4 Row No Knife Dlus with Reloads	Power Medical Interventions, Inc.	GDW	Class II	2004-03-24
K040245	Calibrator for Automated Systems Prealbumin-Aslo-Ceruloplasmin (C.f.a.s. Pac)	Roche Diagnostics GmbH	JIX	Class II	2004-03-24
K040244	Microoptical's Critical Data Viewers, Models Md-3 and Md-6	The Microoptical Corporation	GCJ	Class II	2004-03-24