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 1506 of 3531

510(k) clearances, page 1506 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K022299	Trilux, Z-Tone, Acry Rock	Ruthibras Imp. Exp. Com. de Materiais Odontologico	ELM	Class II	2002-10-07
K022219	Exomio, Model 1.1	Medcom GmbH	KPQ	Class II	2002-10-07
K023124	Canon X-Ray Digital Camera with Additional Software, Lanmix Mlt	Canon, Inc.	MQB	Class II	2002-10-04
K023086	Classic Great Toe Implant	Nexa Orthopedics, Inc.	KWH	Class II	2002-10-04
K023049	Synchron Lx I 725 Clinical System	Siemens Healthcare Diagnostics Inc.	JGS	Class II	2002-10-04
K023022	Nugen Fx Screw	Bionx Implants, Inc.	HWC	Class II	2002-10-04
K023021	Modification to Smith & Nephew Twinfix Ti Quick T	Smith & Nephew, Inc.	HWC	Class II	2002-10-04
K022382	Rhs Acetabular Component	Whiteside Biomechanics, Inc.	LPH	Class II	2002-10-04
K022311	Rhinostream Rhinomanometer Module	Rhino Metrics A/S	BXQ	Class II	2002-10-04
K022276	Kokomate	Ferraris Respiratory, Inc.	BZG	Class II	2002-10-04
K022257	Vomed Peripheral Vascular Accessories, Models 1010 Xxx-7090 Xxx & 9006 Xxx-9011 Xxx	Vomed Volzer Medizintechnik GmbH & Co.	DRC	Class II	2002-10-04
K022210	Multifunctional Electrode Models 9640, 9650	ZOLL Medical Corporation	MKJ	Class III	2002-10-04
K022207	Axya Model 3000 Axyaloop Titanium Bone Anchor System	TORNIER Inc.	MBI	Class II	2002-10-04
K021788	Nbd Cement Restrictor Device	New Business Development, LLC	JDK	Class II	2002-10-04
K021390	Pmx Compact Resucitator	Cheen Houng Ent. Co. Ltd.	BTM	Class II	2002-10-04
K020671	Psa4000 EEG Monitor with Frontal Psi	Physiometrix, Inc.	OLW	Class II	2002-10-04
K014128	Candela Smoothbeam Laser System	Candela Corporation	GEX	Class II	2002-10-04
K013525	Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 Cm X 10Cm), 9613 (6X6 (15Cm X 15Cm)	MEDLINE INDUSTRIES, LP - Northfield	MGQ	Unclassified	2002-10-04
K012344	Vanguard Reprocessed Pulse Oximeter Sensors	Stryker Sustainability Solutions	NLF	Class II	2002-10-04
K012271	Acuteventilator	Impoex International, Ltd.	BTM	Class II	2002-10-04
K023053	Dyonics Vision 635 Image Management System	Smith & Nephew, Inc.	GCJ	Class II	2002-10-03
K022939	Oscor Pace 101/101H and Accessories, St.jude Medical Model 3077 and Accessories,cardiotronic Pace 101 and Accessories	Osypka Medical GmbH	DTE	Class II	2002-10-03
K022910	Qsc-63-Int Shoulder Array Coil Set	Mri Devices Corp.	MOS	Class II	2002-10-03
K022904	Dermagrip-N/multiple/wrp Asia Pacific Sdn Bhd Powder Free Nitrile Examination Gloves, Non-Sterile	WRP Asia Pacific Sdn Bhd	LZA	Class I	2002-10-03
K022896	Csv12 Software Viewer	Acuson Corp.	LLZ	Class II	2002-10-03
K022808	Dermagrip Powder Free Latex Examination Gloves, Non-Sterile with Protein Content Labeling Claim (50 Ug or Less)	Wrp Specialty Products Sdn. Bhd.	LYY	Class I	2002-10-03
K022485	Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-Cane02 and L-Cane02a Software	GE Healthcare	MHX	Class II	2002-10-03
K022475	Modification to Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control, Power Cord, Wands	ArthroCare Corporation	GEI	Class II	2002-10-03
K022300	Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.h., Vipi Dent V	Dental Vipi Ltda	ELM	Class II	2002-10-03
K022266	Aurora Sr	Syneron Medical, Ltd.	GEX	Class II	2002-10-03
K022234	Arthrex Wrist Bio-Anchor, Model Ar-1322B	Arthrex GmbH	HWC	Class II	2002-10-03
K022205	Disposable N-Pe Microkeratome Blades	Oasis Medical, Inc.	HNO	Class I	2002-10-03
K022188	Radianalyzer, Model 12710	Radi Medical Systems AB	DQK	Class II	2002-10-03
K020810	Vidas D-Dimer New (Dd2) Assay Model#30 442	bioMerieux, Inc.	DAP	Class II	2002-10-03
K020334	Insulation and Continuity Tester Plus Accessories; Models Ati014 & Ati014 Fc	Jac-Cell Medic	GEI	Class II	2002-10-03
K023167	Breathable Surgical Gown	Medtronic, Inc.	FYA	Class II	2002-10-02
K023088	Bone Graft Syringe, Model 8600-00X0	Wrightmedicaltechnologyinc	FMF	Class II	2002-10-02
K022966	Proxilock Hip Prosthesis; Size 12/36	Implex Corp.	LWJ	Class II	2002-10-02
K022958	Total Hip Femoral Heads and Liners	Smith & Nephew, Inc.	JDI	Class II	2002-10-02
K022953	Modification to Computed Oral Radiology System	Schick Technologies, Inc.	MUH	Class II	2002-10-02
K022936	Linical Hscrp Calibration Verifiers Levels a-E for Beckman Coulter Immage	Cliniqa Corporation	JJY	Class I	2002-10-02
K022902	Smith & Nephew Hip System	Smith & Nephew, Inc.	LPH	Class II	2002-10-02
K022885	Linical Protein 4 Calibration Verifiers Levels-a-E for Beckman Coulter Immage	Cliniqa Corporation	JJY	Class I	2002-10-02
K022867	Linical Protein 3 Calibration Verifiers Levels a - E for the Beckman-Coulter Immage	Cliniqa Corporation	JJY	Class I	2002-10-02
K022641	Tokuyama Rebase II	Tokuyama America Inc.	EBI	Class II	2002-10-02
K022265	Light Tip	Svenska Dental Instruments AB	EBZ	Class II	2002-10-02
K022264	Clean 'N' Oil	Svenska Dental Instruments AB	EGS	Class I	2002-10-02
K022199	Endius Atavi System	Endius, Inc.	HRX	Class II	2002-10-02
K011208	Biover	Biover AG	DXC	Class II	2002-10-02
K023010	Sniff Position Pillows/popitz Pillows	Aeolus International Corporation	MYB	Class II	2002-10-01