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 1560 of 3531

510(k) clearances, page 1560 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K013838	Ksea Clearvision Lens Irrigation System	Karl Storz Endoscopy-America, Inc.	EOB	Class II	2002-01-16
K013833	Hi-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic Coating, #1009659,1009659J, 1009660, 10096	Boston Scientific Corporation	DQX	Class II	2002-01-16
K013656	Planmed Sophie & Planmed Sophie Classic	Planmed Oy	IZH	Class II	2002-01-16
K013647	Revolution Formula 2	Sybron Dental Specialties, Inc.	EBF	Class II	2002-01-16
K013609	Nexus 2 Clear	Sybron Dental Specialties, Inc.	EMA	Class II	2002-01-16
K013560	Sempermed Supreme, Sizes 5.5, 6, 6.5, 7, 7.5, 8, 8.5, and 9	Semperit Technische Produkte Gesellshaft	KGO	Class I	2002-01-16
K013052	Konica Laser Imager, Drypro Model 751/752	Konica Minolta Medical & Graphic, Inc.	LMC	Class II	2002-01-16
K012486	Osteomed Bioresorbable Fixation System	Osteomed	DZL	Class II	2002-01-16
K011562	Lumend Percutaneous Catheter	Lumend, Inc.	DQY	Class II	2002-01-16
K014181	M2376a Devicelink System, Model M2376a	Philips North America LLC	MWI	Class II	2002-01-15
K014162	Modification to Optimum Cleaning, Disinfecting and	Lobob Laboratories, Inc.	MRC	Class II	2002-01-15
K014161	Sjm Tailor Annuloplasty Ring Model Tarp- (Size)	Abbott Medical	KRH	Class II	2002-01-15
K013978	Synchron Systems Pancreatic Amylase (Pam) Reagent	Siemens Healthcare Diagnostics Inc.	JFJ	Class II	2002-01-15
K013729	Stat Profile Phox Basic Analyzer	Nova Biomedical Corporation	CHL	Class II	2002-01-15
K013574	Accent	Confirma, Inc.	LLZ	Class II	2002-01-15
K013448	Prismasate	Gambro Renal Products	KPO	Class II	2002-01-15
K013447	Isobar Spinal System	Scien'Tx USA, Inc.	KWP	Class II	2002-01-15
K013442	Pass Spinal System	Encore Orthopedics, Inc.	KWP	Class II	2002-01-15
K011649	Randox Valproic Acid	Randox Laboratories, Limited	LEG	Class II	2002-01-15
K011648	Randox Carbamazepine	Randox Laboratories, Limited	KLT	Class II	2002-01-15
K014205	Modification to Bridge Self-Expanding Biliary Stent Delivery System (Bridge Se)	Medtronic, Inc.	FGE	Class II	2002-01-14
K014147	80 Channel EEG	Xltek	GWQ	Class II	2002-01-14
K014146	84 Channel EEG	Xltek	GWQ	Class II	2002-01-14
K013500	Kavo Polylux II	Kavo America	EBZ	Class II	2002-01-14
K013483	Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus Kit	Hollister, Inc.	KOD	Class II	2002-01-14
K013450	Notta Ambulatory Recorder	Stellate Systems	OLV	Class II	2002-01-14
K013439	Anterior Cervical Plate System	Scien'Tx USA, Inc.	KWQ	Class II	2002-01-14
K013425	Heartstream/heartstart Fr2 AED ECG Cable, Models M3860a, M3861a, M3840a, M3841a	Philips North America LLC	MKJ	Class III	2002-01-14
K014121	Warmtouch Cardiac Blanket,catalog # 503-0860	Medtronic, Inc.	DWJ	Class II	2002-01-11
K014118	Modification to Supercross Catheter	Abbott Vascular	DQY	Class II	2002-01-11
K014117	Modification to Outback Catheter	Lumend, Inc.	DQY	Class II	2002-01-11
K014094	Modification to the Watchchild Obstetrical Patient Data Management System	Hill-Rom Manufacturing, Inc.	HGM	Class II	2002-01-11
K013598	Reuse Claim for the Bard Electrophysiology Surelink, Templink, and Templink M Extension Cables	C.R. Bard Inc	DSA	Class II	2002-01-11
K013462	Hydrofera Bacteriostatic Wound Dressing	Hydrofera, LLC.	FRO	Unclassified	2002-01-11
K013429	Actaeon Probe	Osteobiologics, Inc.	NGR	Class II	2002-01-11
K013415	Synthes Ankle Arthrodesis Plate	Synthes (USA) Products LLC	HRS	Class II	2002-01-11
K013391	Bodyfix	3C-Medical Intelligence GmbH	IYE	Class II	2002-01-11
K012112	Randox Digitoxin	Randox Laboratories, Limited	LFM	Class II	2002-01-11
K011597	Smartmonitor 2, Model 4000	Respironics Georgia, Inc.	FLS	Class II	2002-01-11
K003311	Nutrisafe Pur Enteral Feeding Tube	Vygon Corp.	FPD	Class II	2002-01-11
K014250	7Mm Extended Length Endoscope,dissection Tips, Models Vh-1111, Vh-1114	Boston Scientific Corporation	GCJ	Class II	2002-01-10
K014108	Mac 5000 ECG Analysis System	General Electric Medical Systems Information Techn	DQK	Class II	2002-01-10
K014097	Ge Logiq 5	GE Healthcare	IYN	Class II	2002-01-10
K013969	Miniblaster	Deldent, Ltd.	KOJ	Class II	2002-01-10
K013950	Vented Vial Access Device	Vygon Mfg	FPA	Class II	2002-01-10
K013515	Infinity Explorer	Siemens Medical Solutions USA, Inc.	DXJ	Class II	2002-01-10
K013478	Dynapulse 5200A Pathway Blood Pressure Monitoring System	Pulse Metric, Inc.	DXN	Class II	2002-01-10
K013417	Misonix Irrigation System Moedl Bc20p	Misonix, LLC	GBX	Class I	2002-01-10
K013416	Intuitive Surgical Endowrist Endoscopic Instrument Family	Intuitive Surgical, Inc.	GEI	Class II	2002-01-10
K013389	Datex-Ohmeda S/5 Bis Module, M-Bis and Accessories	GE Healthcare	OLW	Class II	2002-01-10