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 1429 of 3531

510(k) clearances, page 1429 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032439	Zoll M Series with Rectilinear Bi-Phasic Option (M Series Bi-Phasic)	ZOLL Medical Corporation	MKJ	Class III	2003-11-05
K032425	Invisiject Resusable Auto-Injector	Biogen	KZH	Class II	2003-11-05
K032130	Vitoss-Filled Cartridge	DSM Biomedical, Inc.	MQV	Class II	2003-11-05
K031073	Perioglas Plus - Settable Bone Graft Substitute	Novabone Products, LLC	LYC	Class II	2003-11-05
K033390	Colibri Disposable Vitrectomy Cutter	Microworld Medical Instruments, Inc.	HQE	Class II	2003-11-04
K033277	Hydragel Csf Isofocusing Kits	Morax	CFF	Class II	2003-11-04
K033274	Giardia II	Techlab, Inc.	MHI	Class II	2003-11-04
K032788	Vitek 2 Gram Negative Gatifloxacin	bioMerieux, Inc.	LON	Class II	2003-11-04
K032597	Biscem Gi	Bisco Inc	EMA	Class II	2003-11-04
K032481	Theratears Contact Lens Comfort Drops	Advanced Vision Research, Inc.	LPN	Class II	2003-11-04
K033346	Spi Easy Dental Implant Protective Cap	Thommen Medical AG	NHA	Class II	2003-11-03
K032804	Cryocheck Weak Lupus Positive Control	Precision BioLogic Inc.	GGC	Class II	2003-11-03
K032764	Barbiturate Enzyme Immunoassay, Ca. # 0140 (500 Tests Kit); Cat# 0141 (5000 Tests Kit)	Lin-Zhi International Inc	DIS	Class II	2003-11-03
K032662	Guttaflow	Coltene/Whaledent GmbH & Co. KG	KIF	Class II	2003-11-03
K031946	Embol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large, Extra-Large	Edwards Lifesciences LLC	DTM	Class II	2003-11-03
K031708	Osteomed Maxillary/lefort III Distraction System	Osteomed	MQN	Class II	2003-11-03
K031042	Atac Hemoglobin A1c Reagent Kit	Clinical Data, Inc.	LCP	Class II	2003-11-03
K033305	Infinity Multiview Infinity Telemetry System	Draeger Medical Systems, Inc.	DSI	Class II	2003-10-31
K033264	Malleable Single Stage Venous Cannula with Carmeda Bioactive Surface, Model Cb681xx Series	Medtronic Perfusion Systems	DWF	Class II	2003-10-31
K033263	K-Tech 2 Power Tilt Seating System, Model K2pt	Track Corporation	ITI	Class II	2003-10-31
K033217	Pheron Pta Catheter	BIOTRONIK AG	DQY	Class II	2003-10-31
K033209	Fukuda Denshi Model Ff Sonic Uf-750Xt	Fukuda Denshi USA, Inc.	IYN	Class II	2003-10-31
K033130	Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse Generator	Osypka Medical GmbH	DTE	Class II	2003-10-31
K033127	Vitros Immunodiagnostic Products Anti-Hbc Controls	Ortho-Clinical Diagnostics, Inc.	JJX	Class I	2003-10-31
K033068	Ionofil Color Ac	Voco GmbH	EMA	Class II	2003-10-31
K033037	Modification to Globalcardio	Cardiocomm Solutions, Inc.	DSH	Class II	2003-10-31
K032993	Vitros Immunodiagnostic Products Anti-Hbc Igm Controls	Ortho-Clinical Diagnostics, Inc.	JJX	Class I	2003-10-31
K032766	Vitek 2 Gram Positive Linezolid	bioMerieux, Inc.	LON	Class II	2003-10-31
K032738	Vitek 2 Gram Positive Quinupristin/dalfopristin	bioMerieux, Inc.	LON	Class II	2003-10-31
K032711	Vitek Gram Negative Gatifloxacin	bioMerieux, Inc.	LON	Class II	2003-10-31
K032573	Dimension Procainamide (Proc) Flex Reagent Cartridge Method, Model Df110	Siemens Healthcare Diagnostics Inc.	LAR	Class II	2003-10-31
K032564	Dimension N-Acetylprocainamide (Napa) Flex Reagent Cartridge Method, Model Df111	Siemens Healthcare Diagnostics Inc.	LAN	Class II	2003-10-31
K032527	Hedrocel Vertebral Body Replacement	Implex Corp.	MQP	Class II	2003-10-31
K032426	Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set	Cook Inc.	DTK	Class II	2003-10-31
K032398	Plus Pivot Link Universal System	Spine Vision, Inc.	MNI	Class II	2003-10-31
K032388	Bone Cement Radio-Opacifier	Cardinalhealth	MYU	Class II	2003-10-31
K032363	Zoll M Series Nibp Option	ZOLL Medical Corporation	DXN	Class II	2003-10-31
K032145	Audicor Upgrade System	Inovise Medical, Inc.	DPS	Class II	2003-10-31
K031963	Conserve Plus Spiked Acetabular Shells and Conserve Total 56Mm Femoral Head	Wrightmedicaltechnologyinc	KWA	Class III	2003-10-31
K031862	Spinerx-Ldm	Spinerx Technology	ITH	Class II	2003-10-31
K031446	Jabes Electronic Stethoscope	Gs Technology Co., Ltd.	DQD	Class II	2003-10-31
K031369	Mercator Healthcare Male Latex Condom	Mercator Healthcare, Ltd.	HIS	Class II	2003-10-31
K030683	Nipro Disposable Syringes	Nipro Medical Corporation	FMF	Class II	2003-10-31
K030358	Kd-622 Fully Automatic Electronic Blood Pressure Monitor	Kodon(Tianjin)Electronic&Electrical Apparatus Co.	DXN	Class II	2003-10-31
K024013	Sun-Rain Ultrasonic Therapy, Su-100	Sun-Rain System Corp.	IMI	Class II	2003-10-31
K013452	Danmar Products Cranial Adjustive Prosthesis	Danmar Products, Inc.	MVA	Class II	2003-10-31
K033257	Arthrocare ENT Plasma Wands	ArthroCare Corporation	GEI	Class II	2003-10-30
K033212	Lifestent Sds Biliary Endoprosthesis	Orbusneich Medical, Inc.	FGE	Class II	2003-10-30
K033211	Ensite System	Endocardial Solutions, Inc.	DQK	Class II	2003-10-30
K033194	Inion Cps Baby 1.5 Bioabsorbable System	Inion Oy	JEY	Class II	2003-10-30