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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 776 of 3530

510(k) clearances, page 776 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K140606	1.5T Procure Array Coil, 3.0T Procure Array Coil	Resonance Innovations, LLC	MOS	Class II	2014-05-12
K140419	Supercath5	Togo Medikit Co., Ltd.	FOZ	Class II	2014-05-12
K140124	S9 Elouera	ResMed Corp	BZD	Class II	2014-05-12
K133718	Zerona	Erchonia Corporation	OLI	Class II	2014-05-12
K133378	Zimmer Trabecular Metal Reverse Shoulder System	Zimmer GmbH	PHX	Class II	2014-05-12
K133054	Endoseal	Maruchi	KIF	Class II	2014-05-12
K133042	Endocem Zr	Maruchi	KIF	Class II	2014-05-12
K132686	Aquarius Low Profile Gastrostomy Feeding Tube	Degania Silicone, Inc.	KNT	Class II	2014-05-12
K132529	Gallieon-1 Medical Laser	Future Device and Technology, Inc.	ILY	Class II	2014-05-12
K131531	Tiankang Disposable Syringes with Re-Use Prevention Feature with or without Needle	Anhui Tiankang Medical Products Co., Ltd.	MEG	Class II	2014-05-12
K131176	Ross Ru Skin Discontinuities	Biotd S.A.	FRO	Unclassified	2014-05-12
K140354	Abbott Multi-Collect Specimen Collection Kit, Abbott Real Time Ct/ng	Abbott Molecular, Inc.	LSL	Class II	2014-05-09
K140122	Candela Gentlemax Family of Laser System	Candela Corporation	GEX	Class II	2014-05-09
K134055	Adx4000w	Dexcowin Co., Ltd.	MUH	Class II	2014-05-09
K133565	Leksell Gamma Knife Perfexion	Elekta Instrument AB	IWB	Class II	2014-05-09
K133251	Bard Dignishield Stool Management System	C.R. Bard Inc	KNT	Class II	2014-05-09
K133203	Single-Site Port	Intuitive Surgical, Inc.	GCJ	Class II	2014-05-09
K131790	A9800 Anesthesia Workstation	Oricare Inc.	BSZ	Class II	2014-05-09
K131711	Yz3 Portable Slit Lamp	Suzhou 66 Vision Tech Co., Ltd.	HJO	Class II	2014-05-09
K131557	Ritter Implant System	Ritter Implants GmbH CO KG	DZE	Class II	2014-05-09
K130775	Duet System	Bioview	NTH	Class II	2014-05-09
DEN130015	Pixel 3 System	Gauss Surgical, Inc.	PBZ	Class II	2014-05-09
DEN120016	Deka Arm System	Deka Integrated Solutions Corporation	PAE	Class II	2014-05-09
K141081	Filtek Bulk Fill Posterior Restroative	3M ESPE Dental Products	EBF	Class II	2014-05-08
K140755	Activecare Dvt, Activecare+sft, and Activecare+dtx Systems	Medical Compression Systems (Dbn), Ltd.	JOW	Class II	2014-05-08
K140607	Aap Loqtec(r) Olecranon Plate	AAP Implantate AG	HRS	Class II	2014-05-08
K140404	Elecsys Ck-Mb Stat Immunoassay	Roche Diagnostics GmbH	JHY	Class II	2014-05-08
K140269	Hermes Medical Imaging Suite V5.4	Hermes Medical Solutions AB	KPS	Class II	2014-05-08
K140252	16 Ch Multipurpose Coil Variety	Noras Rontgen-Und Medizintechnik GmbH	MOS	Class II	2014-05-08
K140206	Scintillation Gamma Camera	Ddd-Diagnostic A/S	KPS	Class II	2014-05-08
K133731	Nobelactive Wide Platform (Wp)	Nobel Biocare AB	DZE	Class II	2014-05-08
K133722	Asthma Monitor Am3	Eresearch Technology	BZG	Class II	2014-05-08
K133200	Stalif C(r)	Centinel Spine, LLC	OVE	Class II	2014-05-08
K132711	Carolina Liquid Chemistries Hdl Cholesterol Reagent	Carolina Liquid Chemistries	LBS	Class I	2014-05-08
K130067	Mrna Appliance	Biomodeling Solutions, Lls	LRK	Class II	2014-05-08
K140941	Progrip Self-Gripping Polypropylene Mesh, Parietene Flat Sheet Mesh	Sofradim Production	FTL	Class II	2014-05-07
K140814	Evos Mini-Fragment Plating System	Smith & Nephew, Inc.	HRS	Class II	2014-05-07
K140311	Caresite Luer Access Device	B.Braun Medical, Inc.	FPA	Class II	2014-05-07
K140238	Excella III-D Spinal Deformity System	Innovasis, Inc	NKB	Class II	2014-05-07
K140070	Luxer Shaded Zirconia	Continental Dental Ceramics, Inc.	EIH	Class II	2014-05-07
K133801	Baxter Sigma Spectrum Infusion Pump with Master Drug Library	Baxter Healthcare Corporation	FRN	Class II	2014-05-07
K133690	True Spinal Fussion System	Innovative Surgical Designs, Inc.	MNH	Class II	2014-05-07
K132870	Origio Gas Line Filter	CooperSurgical, Inc.	MQG	Class II	2014-05-07
K132475	Fluobeam 800 Clinic Laser Imaging Device and Fluocase 800 Control System	Fluoptics	OWN	Class II	2014-05-07
K132397	Gore Bio-a Wound Matrix	W. L. Gore & Associates, Inc.	QSZ	Unclassified	2014-05-07
K140916	Liquichek Cardiac Troponins Control, Levels 1,2 and 3, Trilevel/minipak	Bio-Rad Laboratories Inc.	JJY	Class I	2014-05-06
K140904	Rsp Monoblock Stem with P2 Coating, Size 6	Encore Medical, LP	PHX	Class II	2014-05-06
K140111	Bd Max(tm) Enteric Bacterial Panel;bd Max(tm) Instrument	Becton Dickinson & Co	PCI	Class II	2014-05-06
K131468	Denracle Dental Abutment	Green Dentech Co, Ltd.	NHA	Class II	2014-05-06
K122656	Powder-Free Vinyl Patient Examination Gloves, Yellow Color	Shandong Yifan Plastic Products Co., Ltd.	LYZ	Class I	2014-05-06