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 1437 of 3531

510(k) clearances, page 1437 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K022505	Contra-Angle, Models 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,	Nouvag AG	EGS	Class I	2003-10-01
K032875	Aloka Model Ssd-5500 V6.0 Ultrasound System	Aloka Co. Ltd USA	IYO	Class II	2003-09-30
K032701	Surgassist Circular Stapler Digital Loading Units (Cs21, Cs25, Cs29, Cs33)	Power Medical Interventions, Inc.	GDW	Class II	2003-09-30
K032693	Duragen Plus Dural Graft Matrix	Integra LifeSciences Corporation	GXQ	Class II	2003-09-30
K032321	Cera F Alloy	Dentsply International, Inc.	EJT	Class II	2003-09-30
K032319	Cera R Plus Alloy	Dentsply International, Inc.	EJT	Class II	2003-09-30
K032318	Minerva 58 Alloy	Dentsply International, Inc.	EJT	Class II	2003-09-30
K032317	Orion Gx Alloy	Dentsply Intl.	EJT	Class II	2003-09-30
K032316	Orion E Alloy	Dentsply Intl.	EJT	Class II	2003-09-30
K032247	u.s. Technologies, Inc. Retractable Safety Syringe	U.S. Technologies, Inc.	MEG	Class II	2003-09-30
K032161	Phem-Alert	Femtek,Llc.	LNW	Class I	2003-09-30
K032116	Tulip Colorswitch	Cavex Holland B.V.	ELW	Class II	2003-09-30
K032076	Senova(r) Blood Glucose Monitor	Chdiagnostics, LLC	LFR	Class II	2003-09-30
K031652	Vascupuncture Picc Guidewire	Neometrics, Inc.	DQX	Class II	2003-09-30
K030044	Extended Range Hs Crp Kit, Cat No:9200	Reference Diagnostics, Inc.	DCK	Class II	2003-09-30
K032275	Bd Phoenix Automated Microbiology System-Imipenem 1-16 Ug/ml Gram-Negative Id/ast or Ast Only Phoenix Panels	Becton Dickinson & Co	LON	Class II	2003-09-29
K032240	Bindazyme Human Anti-Phosphatidylserine Iga, Igg and Igm Enzyme Immunoassay Kit	The Binding Site	MID	Class II	2003-09-29
K032232	Airis Elite Magnetic Resonance Imaging Device	FUJIFILM Healthcare Americas Corporation	LNH	Class II	2003-09-29
K032042	Envision	Sybron Dental Specialties, Inc.	DYH	Class II	2003-09-29
K031974	Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0	asap endoscopic products GmbH	HIH	Class II	2003-09-29
K031960	Intralase Fs Laser	Intra Lase Corp.	GEX	Class II	2003-09-29
K031225	Timesh Also Known as Timesh-Tc, Models 6000001 & 6000004	Gfe Medizintechnik GmbH	FTL	Class II	2003-09-29
K031031	Vitros Immunodiagnostic Products Troponin I Reagent Pack and Calibrators	Ortho-Clinical Diagnostics, Inc.	MMI	Class II	2003-09-29
K030803	Parapac 200D Transport, Model V200d	Pneupac, Ltd.	BTL	Class II	2003-09-29
K030050	Toraysulfone Dialyzer, Bs-L Series	Toray Industries (America), Inc.	KDI	Class II	2003-09-29
K030003	Atac Direct Bilirubin Reagent and Calibrator	Elan Diagnostics	CIG	Class II	2003-09-29
K023778	Dressskin	Integra LifeSciences Braintree Inc.	KGN	Unclassified	2003-09-29
K023626	Aml Haircheck-Dt (Cocaine)	Quest Diagnostics, Inc.	DIO	Class II	2003-09-29
K023103	Depuy 1 Gentamicin Bone Cement	Depuy Orthopaedics Inc.	LOD	Class II	2003-09-29
K022490	Ksea Medi Pack	Karl Storz Endoscopy-America, Inc.	GCT	Class II	2003-09-29
K032892	Modification to Trubyte Denture Base Resin System	Dentsply Intl.	EBI	Class II	2003-09-26
K032851	Ultracrown 75 Alloy	Dentsply International, Inc.	EJT	Class II	2003-09-26
K032847	Excisor Bioptome, Model 01-0004	Acueity, Inc.	KNW	Class II	2003-09-26
K032838	Celon ENT System	Celon AG Medical Instruments	GEI	Class II	2003-09-26
K032832	Irrigation Sets	Vital Concepts, Inc.	HRX	Class II	2003-09-26
K032715	Dw 296 #15 Solder	Ivoclar Vivadent, Inc.	EJT	Class II	2003-09-26
K032684	Raycell	Mds Nordion	MOT	Unclassified	2003-09-26
K032680	Smith & Nephew 300Xl Xenon Light Source-Hermes Ready Model, 7210045	Smith & Nephew, Inc.	GCJ	Class II	2003-09-26
K032342	Coulter Lh 750 Hematology Analyzer	Siemens Healthcare Diagnostics Inc.	GKZ	Class II	2003-09-26
K032151	Depuy Sigma Tibial Inserts and Co-Cr Tibial Trays	Depuy, Inc.	JWH	Class II	2003-09-26
K031308	Rhigene Mesacup-2 Anti-Mitochondria M2 Test, Model 10760	Rhigene, Inc.	DBM	Class II	2003-09-26
K030014	Atac Total Bilirubin Reagent	Elan Diagnostics	CIG	Class II	2003-09-26
K024076	Maky 21.1 Dialyzer Reprocessing System	Hdc Maquinolas, LLC	LIF	Class II	2003-09-26
K032633	Hrk-63-8 Knee Array Coil	Mri Devices Corp.	MOS	Class II	2003-09-25
K032591	Numed Tyshak Mini Pediatric Ptv Catheter	Numed Inc	DQY	Class II	2003-09-25
K032550	Exomio, Model 2.0 Sp1	Medcom GmbH	KPQ	Class II	2003-09-25
K032497	Sapphire Vds Tension Safe Detachable Coil, E-3-12/3-T10-Vt	Medtronic, Inc.	HCG	Class II	2003-09-25
K032355	Orthoralix 9200 Dde, Orthoralix 9200 Dde Plus Ceph, Models 5105 0161Ww, 5105 0181Ww	Dentsply Gendex	EHD	Class II	2003-09-25
K032248	Precise Carbon Fiber Table Top, Model 11-999	Aktina Medical Physics Corp.	IYE	Class II	2003-09-25
K032176	Rattan Imacs by Rattan Information Corporation	Rattan Information Corporation	LLZ	Class II	2003-09-25