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 1257 of 3531

510(k) clearances, page 1257 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K052513	Baby Snoopy Water Filled Teether, Model 95367	Delta Enterprise Corporation	KKO	Class II	2006-06-28
K061684	Medi-Globe Rota-Cut Sphincterotome	Medi-Globe GmbH	KNS	Class II	2006-06-27
K061646	Laserscope Guided Delivery Device (Gdd) Cystourethroscope & Accessories	Laserscope	FBO	Class II	2006-06-27
K061624	Vitrea, Version 3.9	Canon Medical Informatics, Inc.	LLZ	Class II	2006-06-27
K061609	Ge Datex-Ohmeda Aisys	GE Healthcare	BSZ	Class II	2006-06-27
K061527	Card 43 Cardiotomy Reservoir with Phosphorylcholine Coating	Corcym Inc.	DTN	Class II	2006-06-27
K061440	P.d	.Decimal, Inc.	MUJ	Class II	2006-06-27
K061360	Neomarkers Rabbit Monoclonal Anti-Human Estrogen Rece[ptor Antibody (Clone Sp1)	Lab Vision Corp.	MYA	Class II	2006-06-27
K061280	V-2200 Infant Incubator	Neoforce Group, Inc.	FMZ	Class II	2006-06-27
K061210	Functional Anaesthetic Discography (Fad) Catheter System, Model D01a ; Introducer Needle, Model D01b	Medtronic, Inc.	BSP	Class II	2006-06-27
K061043	Zimmer Contour Restorative System	ZimVie US Corp LLC	NHA	Class II	2006-06-27
K060848	Bod Pod	Life Measurement, Inc.	OAC	Class II	2006-06-27
K060030	The Double Glove	Biobarrier, Inc.	KGO	Class I	2006-06-27
K052291	Capillary's Hemoglobin(e) (Pn 2007)	Sebia	GKA	Class II	2006-06-27
K061625	Autobone2	GE Healthcare	JAK	Class II	2006-06-26
K061487	Duramatrix Collagen Dura Substitute Membrane - Onlay and Suturable	Collagen Matrix, Inc	GXQ	Class II	2006-06-26
K061427	Pre-Impression Conditioning Solution	Dentsply Intl.	ELW	Class II	2006-06-26
K061161	Blood Pressure Meter, Model Ch-311B	Citizen Watch Co., Ltd.	DXN	Class II	2006-06-26
K061159	Opticath Central Venous Oximetry Probe with Fluidic Seal With/without Heparin	Abbott Medical	DQE	Class II	2006-06-26
K060939	Ranger Irrigation Fluid Warming System	Arizant Healthcare, Inc.	LGZ	Class II	2006-06-26
K053476	Allwound	At Squared, LLC	SEJ	Unclassified	2006-06-26
K051573	Tgp (Gutta Percha Containing Tetracycline or Doxycycline)	Dr. Howard Martin, P.A.	EKM	Class I	2006-06-26
K061587	Fullcard Analysis	GE Healthcare	KPS	Class II	2006-06-23
K061563	Ebi Array Spinal System	Ebi, LLC	NKB	Class II	2006-06-23
K061520	Viper Spine System	DePuy Spine, Inc.	NKB	Class II	2006-06-23
K061443	Smart Usblite, Model M011120	Intelligent Hearing Systems Corp.	GWJ	Class II	2006-06-23
K061395	Calset Composite Heater	Addent, Inc.	EBZ	Class II	2006-06-23
K061302	Digital Printer P6000d Series, Model P6000du	Mitsubishi Electric Corporation Kyoto Works	LMC	Class II	2006-06-23
K061301	Copan Liquid Amies Elution Swab (Eswab) Collection and Transport System	COPAN Diagnostics, Inc.	JTW	Class I	2006-06-23
K061254	Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222	Medtronic Perfusion Systems	DWF	Class II	2006-06-23
K061193	Creatinine	Abbott Medical	CGX	Class II	2006-06-23
K061057	Breas Isleep 20+	Breas Medical AB	BZD	Class II	2006-06-23
K061038	Barrierplus Platinum Powder-Free Synthetic Polychloroprene Surgical Gloves, Models 12544-125490	Barriermed Glove Co.	KGO	Class I	2006-06-23
K061034	BIPAP Plus M-Series Bi-Level System	Respironics, Inc.	BZD	Class II	2006-06-23
K060900	Spacelabs Medical Bispectral Index (Bisx) Analysis Module 91482 and Accessories Model-91842	GE Healthcare	OLW	Class II	2006-06-23
K060888	Acell Powder Wound Dressing	Acell, Inc.	KGN	Unclassified	2006-06-23
K060883	Pilot Test or Detective Audiometers	Interacoustics a/S	EWO	Class II	2006-06-23
K060745	Asahi Tornus Support Catheter with Torque Device Accessory	Asahi Intecc Co., Ltd.	DQY	Class II	2006-06-23
K060509	Palindrome Emerald 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating	Tyco Healthcare Group LP	NYU	Class II	2006-06-23
K060483	Volcano Angio-Ivus Mapping (Aim) System	Volcano Corporation	IYO	Class II	2006-06-23
K060316	Compat Go Enteral Feeding Pump and Administration Sets	Fresenius Kabi Deutschland GmbH	LZH	Class II	2006-06-23
K060281	Vs-800 Vital Signs Monitor	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	MHX	Class II	2006-06-23
K060243	Olympus Guide Sheath, Model Xbo1-836-13	Olympus Medical Systems Corp.	EOQ	Class II	2006-06-23
K053562	Zimmer Collagen Repair Patch	Tissue Science Laboratories, PLC	FTM	Class II	2006-06-23
K053195	Spiderx Embolic Protection Device	Medtronic, Inc.	NFA	Class II	2006-06-23
K052908	Intraredx Nir Imaging System, Model Mc-5	Nipro Vascular Innovations Americas, Inc.	DQO	Class II	2006-06-23
K052767	Afibalert Atrial Fibrillation Detector	Lechnologies Research, Inc.	DXH	Class II	2006-06-23
K052711	Emjoi TENS Device	Emjoi, Inc.	GZJ	Class II	2006-06-23
K061605	Nemio Xg, Saa-580A	Toshiba America Medical Systems, In.C	IYN	Class II	2006-06-22
K061503	Dimension Cyclosporine Extended Range Calibrator (Dc108a)	Siemens Healthcare Diagnostics Inc.	DLJ	Class II	2006-06-22