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 2258 of 3531

510(k) clearances, page 2258 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K923531	Optoscalpel I Laser System	Optomed	HQB	Class II	1993-11-12
K920689	Deemed Mss -- Microscope Support System	Deemed, Inc.	FSO	Class I	1993-11-12
K933868	Angiolaz Video Endoscopic System Model Camlum1 and Accessories	Angiolaz, Inc.	GCT	Class II	1993-11-10
K932697	Isi(r) Hook Suture Scissors, Monopolar	Innovative Surgical, Inc.	GCJ	Class II	1993-11-10
K932641	Empty Mixing Container	Douglas Medical Products, Inc	KPE	Class II	1993-11-10
K932640	Eva Empty Mixing Container	Douglas Medical Products, Inc	KPE	Class II	1993-11-10
K932301	Fenwal(r) 40/150 Micron Dual Screen Filter	Baxter Healthcare Corporation	FPB	Class II	1993-11-10
K931968	Cdi 100 Extracorporeal Hematocrit/oxygen Saturatio	3M Company	DRY	Class II	1993-11-10
K931928	Jarit Surgical Instruments	J. Jamner Surgical Instruments, Inc.	GCJ	Class II	1993-11-10
K930689	Autobead Thyroid Uptake	Bio-Chem Laboratory Systems, Inc.	KHO	Class I	1993-11-10
K930322	Free Thyroxine(f T4) Method/technicon Immuno 1(R)	Kulzer GmbH	CEC	Class II	1993-11-10
K926362	Glucostix Reagent Strips	Kulzer GmbH	CGA	Class II	1993-11-10
K924320	Ultra Thin Balloon Dilatation Catheter	Boston Scientific Corporation	LIT	Class II	1993-11-10
K934271	Beckman Synchron Lactate Reagent	Beckman-Diagnostic Systems Group	KHP	Class I	1993-11-09
K934147	Dupont Aca Methadone (Umeth) Screen Test Pack	E.I. Dupont de Nemours & Co., Inc.	DJR	Class II	1993-11-09
K934145	Dupont Aca Urine Methadone Control	E.I. Dupont de Nemours & Co., Inc.	LAS	Class I	1993-11-09
K934144	Dupont Aca Urine Methadone Calibrator	E.I. Dupont de Nemours & Co., Inc.	DLJ	Class II	1993-11-09
K933764	Life-Air 1000 Patient Warming Cover	Progressive Dynamics, Inc.	DWJ	Class II	1993-11-09
K932727	Cholestech L.d.x. System	Cholestech Corp.	CGA	Class II	1993-11-09
K932517	Iron/uibc Reagent	Sigma Diagnostics, Inc.	JMO	Class I	1993-11-09
K932370	Remington Medical Dispos Tear-Away Vasc Intro Set	Remington Medical	DYB	Class II	1993-11-09
K932323	Percutaneous Introducer	Greatbatch Medical	DYB	Class II	1993-11-09
K932084	Aia-Pack E2 Assay	Tosoh Medics, Inc.	CHP	Class I	1993-11-09
K931923	Dantec Maglite Magnetic Stimulator (Maglite)	Dantec Medical, Inc.	GWF	Class II	1993-11-09
K930675	Mitek Cone Washer	Mitek Surgical Products, Inc.	KGS	Class I	1993-11-09
K926467	Cobe Cms-Fs Membrane Oxygenator	LivaNova USA, Inc.	DTZ	Class II	1993-11-09
K923330	The Western Cortical Electrode Array	University Hospital (London) Development Corp.	GYC	Class II	1993-11-09
K922211	Osteomed Great Toe System	Osteomed	LZJ	Unclassified	1993-11-09
K921261	Electric Powered Breast Pump	Schuco, Inc.	HGX	Class II	1993-11-09
K914866	Itc Contour Emboli, Modification	Interventional Therapeutics Corp.	HCG	Class II	1993-11-09
K934474	Pilot Cardiovascular Systems 2 Cm Pilot Wire	Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard	DQX	Class II	1993-11-08
K934367	Pc-Mini	GE Healthcare	JYD	Class I	1993-11-08
K933774	Imc Saline Wet Dressing	Inman Medical Corp.	FRO	Unclassified	1993-11-08
K933100	Arc-600	B C Medical, Ltd.	JAA	Class II	1993-11-08
K930709	Philips Gyroscan Acs-II Release 3	Philips North America LLC	LNH	Class II	1993-11-08
K926333	CPR Plus	Kells Medical, Inc.	LIX	Class II	1993-11-08
K926162	580Cd Display Driver	Vidco, Inc.	DXJ	Class II	1993-11-08
K925653	Dermapunch Disposable Skin Biopsy Punch	Dermatopathology Laboratory	MDM	Class I	1993-11-08
K925607	Ha Anatomic Hip Prosth W/ti-Nidium Surf Hard Proce	Zimmer GmbH	MEH	Class II	1993-11-08
K923211	Digital Ophthalmic Ultrasound Biomicroscope	Zeiss Humphrey System	IYO	Class II	1993-11-08
K921716	Disposable Unipolar Coagulator Probe System	American Surgical Instruments Corp.	HET	Class II	1993-11-08
K934143	N-Assay Tia Microalbumin Calibrator Set	Crestat Diagnostics, Inc.	JIX	Class II	1993-11-05
K934136	Olympus Chloride Reagent, Modification	Olympus Corp.	CHJ	Class II	1993-11-05
K933581	Powermatic Treatment Table	Medical Device Inspection Company	INQ	Class I	1993-11-05
K933580	Power Work Table	Medical Device Inspection Company	INQ	Class I	1993-11-05
K933578	Powermatic Mat Platform	Medical Device Inspection Company	INQ	Class I	1993-11-05
K933142	Access Vitamin B12 Assay	Bio-Rad Laboratories Inc.	CDD	Class II	1993-11-05
K933128	Synelisa Progesterone	Elias U.S.A., Inc.	JLS	Class I	1993-11-05
K932752	Visi-Spot	J.S. Medical Assoc.	JTO	Class I	1993-11-05
K932724	Spacelabs Medical Integrated Clinical Display	GE Healthcare	DXJ	Class II	1993-11-05