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 1241 of 3531

510(k) clearances, page 1241 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K062072	Pajunks Disposable Inserts for Handle Instruments and HF Electrodes	Pajunk GmbH Medizintechnologie	GEI	Class II	2006-09-22
K062049	Evis Exera II 180 System	Olympus Medical Systems Corp.	NWB	Class II	2006-09-22
K061979	Modification to Myallergy Test	Immunetech Corporation	JKA	Class II	2006-09-22
K061852	Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low, Medium, High	Siemens Healthcare Diagnostics Inc.	CZW	Class II	2006-09-22
K061598	Hemosil Homocysteine and Controls	Instrumentation Laboratory Co.	LPS	Class II	2006-09-22
K061528	Selfcheck Gluco	Card Guard Scientific Survival, Ltd.	CGA	Class II	2006-09-22
K061311	Allogran-R	Biocomposites, Ltd.	MQV	Class II	2006-09-22
K061155	Vista P Vertebral Body Replacement System	Zimmer Trabecular	MQP	Class II	2006-09-22
K060919	Actical	Respironics, Inc.	GWK	Class II	2006-09-22
K060917	Kensey Nash Bone Void Filler	DSM Biomedical, Inc.	MQV	Class II	2006-09-22
K060763	Stryker Injectable Cement	Stryker Corp.	GXP	Class II	2006-09-22
K062650	Ep Navigator Software	Philips North America LLC	LLZ	Class II	2006-09-21
K062639	Modification to Hexapod Rt Couch Top	Medical Intelligence Medizintechnik-GmbH-An Elekta	JAI	Class II	2006-09-21
K062457	Infusor Small Volume Elastomeric Infusion Devices	Baxter Healthcare Corporation	MEB	Class II	2006-09-21
K062452	Kit Mendec Spine and Delivery System	Tecres SpA	NDN	Class II	2006-09-21
K062423	Omniguide Beampath Laser Beam Delivery System	Omni-Guide Holdings, Inc.	GEX	Class II	2006-09-21
K062402	Easystand Evolv	Invacare GmbH	INO	Class II	2006-09-21
K062238	Tytan Blood Pressure Cuff	Tytan Medical Corp.	DXQ	Class II	2006-09-21
K061910	Synthes (USA) [Synthes] Angular Stable Locking System (Asls)	Synthes (USA) Products LLC	HSB	Class II	2006-09-21
K061787	Maxforce Tts Single-Use Balloon Dilator	Boston Scientific Corporation	KNQ	Class II	2006-09-21
K061507	Sonicweld Rx Endobrow Fixation	KLS-Martin L.P.	JEY	Class II	2006-09-21
K061494	Dermadapt Wound Dressing	Pegasus Biologics, Inc.	KGN	Unclassified	2006-09-21
K061473	Surgi-Wrap Mast Bioresorbable Sheet	MAST Biosurgery USA, Inc	FTL	Class II	2006-09-21
K062611	Iguide System	Medical Intelligence Medizintechnik-GmbH-An Elekta	IYE	Class II	2006-09-20
K062594	Modification to Polarcath Peripheral Dilatation System	Boston Scientific Corporation	DQY	Class II	2006-09-20
K062448	Lyra Acupuncture Needles	Helio Medical Supplies, Inc.	MQX	Class II	2006-09-20
K062283	The Philips Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp80, Mp90 Intellivue Patient Monitors	Philips North America LLC	MHX	Class II	2006-09-20
K062275	Rinspiration Catheter System, Models 50135, 550135, P7065, P70135	Kerberos Proximal Solutions, Inc.	QEZ	Class II	2006-09-20
K062172	Fetch Aspiration Catheter	Possis Medical, Inc.	QEZ	Class II	2006-09-20
K062093	Avea Ventilator	ZOLL Palm Springs	CBK	Class II	2006-09-20
K062086	Navivision	Brainlab, Inc.	HAW	Class II	2006-09-20
K061871	Leica Model Fl800	Leica Microsystems, Inc.	IZI	Class II	2006-09-20
K061023	Thermosuit System	Life Recovery Systems HD, LLC	NZE	Class II	2006-09-20
K062596	Microstrep Plus Panel Amoxicillin/clavulanic Acid	Siemens Healthcare Diagnostics Inc.	LRG	Class II	2006-09-19
K062585	Microscan Microstrep Plus Panel Azithromycin	Siemens Healthcare Diagnostics Inc.	LRG	Class II	2006-09-19
K062488	Iq-System Pacs System	Image Information Systems, Ltd.	LLZ	Class II	2006-09-19
K062278	Spacelabs Medical Clinical Event Interface, Model 91847	GE Healthcare	MSX	Class II	2006-09-19
K062235	Easy Check Td-4209 Blood Glucose Monitoring System; Clever Check Td-4222, Td-4225, Td-4226 Blood Glucose Monitoring Syst	Taidoc Technology Corporation	NBW	Class II	2006-09-19
K061992	Easyplus Self Monitoring Glucose Test System, Model Eps04014	Eps Bio Technology Corp.	CGA	Class II	2006-09-19
K061990	Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3 Control	Siemens Healthcare Diagnostics Inc.	DCF	Class II	2006-09-19
K061945	Vitek 2 Ast-Ys Fluconazole	bioMerieux, Inc.	NGZ	Class II	2006-09-19
K061813	Mantis Spinal System	Howmedica Osteonics Corp	MNH	Class II	2006-09-19
K061790	Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization Particles	Protein Polymer Technologies, Inc.	KRD	Class II	2006-09-19
K061763	Arc Surgical Biotrak Screw	Arc Surgical, LLC	HWC	Class II	2006-09-19
K061573	Transpac III Disposable Straight Pressure Transducer and Kit	Abbott Medical	DRS	Class II	2006-09-19
K061339	Hierspec Speculum	Medical Products Div.	HIB	Class II	2006-09-19
K053254	Infant Heel Warmer by Intco	Shanghai Intco Medical Supply Co., Ltd.	MPO	Class I	2006-09-19
K062655	Powdered (White) Vinyl Patient Examination Gloves	Shijiazhuang Junfei Plastic Products Co., Ltd.	LYZ	Class I	2006-09-18
K062578	Digi-Lite Tcd Device	Rimed, Ltd.	IYN	Class II	2006-09-18
K062390	Crystalview R200	Alara, Inc.	MQB	Class II	2006-09-18