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 1239 of 3531

510(k) clearances, page 1239 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K061585	Opticath Central Venous Oximetry Catheter	Abbott Medical	DQE	Class II	2006-10-05
K061575	Olympus Calcium Arsenazo Reagent, Osr60117, Osr61117, Osr65117	OLYMPUS Corporation of the Americas	CJY	Class II	2006-10-05
K061465	Kmi Cement Restrictor Implant	Kinetikos Medical, Inc.	JDK	Class II	2006-10-05
K061408	Euroimmun Endomysium Ifa: Esophagus (Monkey) Kit	Euroimmun US Inc.	MVM	Class II	2006-10-05
K062801	Smartsuction Solo Device	Haemonetics Corporation	BTA	Class II	2006-10-04
K062617	Modification to Inion Otps Biodegradable Fixation System	Inion Oy	HWC	Class II	2006-10-04
K062549	Xltek Stimulator Probes, Models 105233, 105234, 105235, 105236, 105237 and 105238	Excel Tech., Ltd.	ETN	Class II	2006-10-04
K062311	Karma Manual Wheelchair, Model Budget 800	Karma Medical Products Ltd.	IOR	Class I	2006-10-04
K062227	V.a.c. Therapy System	Kci USA, Inc. (Kinetic Concepts, Inc.)	OMP	Class II	2006-10-04
K062035	Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and Control	Siemens Healthcare Diagnostics Inc.	JIX	Class II	2006-10-04
K061998	Premier Self-Etching Bond Enhancer	Premier Dental Products Co	KLE	Class II	2006-10-04
K061997	Premier Self-Etching Enamel Sealant	Premier Dental Products Co	EBC	Class II	2006-10-04
K061616	Coulter Lh 780 Hematology Analyzer	Siemens Healthcare Diagnostics Inc.	GKZ	Class II	2006-10-04
K061509	Tigris Dts Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1196	Hologic, Inc.	LSL	Class II	2006-10-04
K061005	Accustep Doa Single and Multi-Strip Screen Panels	Applied Dna Technologies, Inc.	DKZ	Class II	2006-10-04
K062751	Modification to Quantimetrix Cardiasure Cardiac Marker	Quantimetrix Corp.	JJT	Class I	2006-10-03
K062113	Solar Reunion Fracture Stem	Howmedica Osteonics Corp	KWS	Class II	2006-10-03
K062040	Sbi Trihedron Mtp Hemi Gt	Small Bone Innovations, Inc.	KWD	Class II	2006-10-03
K061996	Sandman Pocket	EB Neuro S.p.A.	MNR	Class II	2006-10-03
K060781	Medical Compressor, Models Dk50 D and Dm	Ekom s.r.o.	BTI	Class II	2006-10-03
K062366	Optime, Sinusorb Pga	Peters Surgical	GAM	Class II	2006-10-02
K062344	Grandio Seal	Voco GmbH	EBC	Class II	2006-10-02
K062320	Surgisis Peyronie's Repair Graft, Model Spr-100	Cook Biotech, Inc.	FTM	Class II	2006-10-02
K062244	Opus Smartstich Suture Device with Perfectpasser Connector	ArthroCare Corporation	OCW	Class II	2006-10-02
K062180	Abx Pentra Amylase Cp; Multical; N Control; P Control; Clean-Chem Cp; Clean-Chem 99 Cp	Horiba Abx	JFJ	Class II	2006-10-02
K061746	Collaguard, Model Fcia,fcib,fcic,and Fcid	Innocoll Pharmaceuticals	KGN	Unclassified	2006-10-02
K061145	Spermslow	Medicult A/S	MQL	Class II	2006-10-02
K062747	Arthrex Retrobutton, 15Mm, 60Mm, Retrobutton, Long, 15Mm, 60Mm	Arthrex GmbH	HRS	Class II	2006-09-29
K062725	Maxiflex-Semi Flex Scope	Technology Delivery Systems, Inc.	FGB	Class II	2006-09-29
K062693	Gladiator Bipolar System	Wrightmedicaltechnologyinc	KWY	Class II	2006-09-29
K062654	Depuy Sigma Cruciate Retaining Porocoat Femoral Components	Depuy Orthopaedics Inc.	MBH	Class II	2006-09-29
K062586	Xplorer 1600 Plus	Imaging Dynamics Company, Ltd.	MQB	Class II	2006-09-29
K062576	Datex-Ohmeda S/5 E-Psm(p) Module (Consisting of E-Psm, E-Psmp and E-Intpsm Modules) and Accessories	GE Healthcare	MHX	Class II	2006-09-29
K062501	Validate Thyroid Calibration Verification / Linearity Test Set, Model 901	Maine Standards Co.	JJX	Class I	2006-09-29
K062462	Non-Invasive Blood Pressure Monitor, Models Ft-500R/l and Ft-700R/l	Jawon Medical Co., Ltd.	DXN	Class II	2006-09-29
K062428	Ventana Image Analysis System, Model Vias	Becton Dickinson & Co	NQN	Class II	2006-09-29
K062365	Arthrex Aspirate Kit	Arthrex GmbH	FMF	Class II	2006-09-29
K062304	Dlm112 Daylink Monitor	Rtx Healthcare A/S	DRG	Class II	2006-09-29
K062242	Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and Controls	Lin-Zhi International Inc	LAF	Class II	2006-09-29
K062095	Mcare 300 Vital Signs Monitor, Model 91220	GE Healthcare	MHX	Class II	2006-09-29
K061942	Tympanic Temperature Probe with Foam, Model M1024233; without Foam Model M1024237	GE Healthcare	FLL	Class II	2006-09-29
K061851	Zirkonzahn Ice	Zirkonzahn SRL	EIH	Class II	2006-09-29
K061850	Mini-Yag Laser	American Lasers, Inc.	GEX	Class II	2006-09-29
K061568	Codman Eds 3 Csf External Drainage System, Models 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738	Cerenovus, Inc.	JXG	Class II	2006-09-29
K061319	Spectra System	Implant Direct, LLC	DZE	Class II	2006-09-29
K061250	Multicath Expert	Vygon Corp.	FOZ	Class II	2006-09-29
K061138	Abx Pentra 400 : Crp	Horiba Abx	DCK	Class II	2006-09-29
K060153	Acumed Laser, Model 1000	Laser Thera, LLC	ILY	Class II	2006-09-29
K060012	Clirpath Turbo Peripheral Catheters	Spectranetics Corp.	PDU	Class II	2006-09-29
K052870	Integuseal Microbial Sealant, Model Is 100 and 1S200	Kimberly-Clark Corporation	NZP	Class II	2006-09-29