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 1900 of 3531

510(k) clearances, page 1900 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K970871	Tr Needle	Gallini Intl., Inc.	KNW	Class II	1997-05-21
K970642	Tenoscope	Luxtec Corp.	HRX	Class II	1997-05-21
K970189	Fif Tm	Panbio Limited	KQJ	Class II	1997-05-21
K965133	Anca Combi Diagnostic Test Kit	The Binding Site	MOB	Class II	1997-05-21
K965094	Hycor Allergen Disc	Hycor Biomedical	DHB	Class II	1997-05-21
K964978	Vital Statistics System (O-Cath Accessory)	Quinton, Inc.	DQA	Class II	1997-05-21
K964922	Drake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate Delivery System	Althin Medical AB an Affiliate of Baxter Intl	KDI	Class II	1997-05-21
K964635	Nichols Advantage Chemiluminescence Calcitonin Kit	Nichols Institute Diagnostics	JKR	Class II	1997-05-21
K964551	Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice Exchange Super Support Ptca Guid	Scimed Life Systems, Inc.	DQX	Class II	1997-05-21
K964506	Roche Cobas Amplicor Analyzer	Roche Molecular Systems Inc	JJF	Class I	1997-05-21
K964329	Unipolar Hook Electrode (5Mm .340Mm)/unipolar Hook Electrode (5Mm. 420Mm)	Richard Wolf Medical Instruments Corp.	GEI	Class II	1997-05-21
K963254	Symphony Nitinol Stent Transhepatic Biliary System	Boston Scientific Corporation	FGE	Class II	1997-05-21
K971574	Jelbond-Pdf	J.F. Jelenko & Co., Inc.	EJT	Class II	1997-05-20
K971515	Promed 38 Sofblu (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens (Tinted, Lathe-Cut Form Lens Blank)	Bio-Med Devices, Inc.	LPL	Class II	1997-05-20
K971455	Clarus Model 5197 Sightlite	Clarus Medical Systems, Inc.	FTI	Class II	1997-05-20
K971432	Prospore	Raven Biological Laboratories, Inc.	FRC	Class II	1997-05-20
K971431	Umi X-Ray Film Cassette	Umi Intl.	IXA	Class II	1997-05-20
K971373	Vista Single Chip Video Camera	Vista Medical Technologies, Inc.	FET	Class II	1997-05-20
K971292	Jel-71 Pdf	J.F. Jelenko & Co., Inc.	EJT	Class II	1997-05-20
K971277	Safe-T-Clamp	Talon Medical, Ltd.	KNA	Class II	1997-05-20
K970999	Sony Pgm-100P1md Trinitron Color Graphic Monitor	Sony Medical Systems	JAK	Class II	1997-05-20
K970908	Howtek 960	Howtek, Inc.	LMA	Class II	1997-05-20
K970875	Endolight Fiberoptic Endo-Illuminator (20 Ga. & 19 Ga.)	American Medical Devices, Inc.	MPA	Class II	1997-05-20
K970873	Endosoft Soft Tip Needle (20 Ga. and 19 Ga.)	American Medical Devices, Inc.	HMX	Class I	1997-05-20
K970690	Locking Stylet 2	Cook Pacemaker Corp.	DQX	Class II	1997-05-20
K970647	Our Rotating Gamma System	Our Scientific Intl., Inc.	IWB	Class II	1997-05-20
K970466	Radius Ptca Guidewire	Radius Medical Technologies, Inc.	LIT	Class II	1997-05-20
K964868	2.9F Cragg-Mcnamara Valved Infusion Catheter	Medtronic, Inc.	KRA	Class II	1997-05-20
K964702	Euclid Systems Corneal Topographer Model Et800	Euclid Systems Corp.	MMQ	Class I	1997-05-20
K963781	Zoll Autoclavable Internal Handles	ZOLL Medical Corporation	LDD	Class II	1997-05-20
K962899	Ultraflex Diamond	Boston Scientific Corporation	FGE	Class II	1997-05-20
K962009	Urostym	Abbott Medical	KPI	Class II	1997-05-20
K945590	Scopetex(tm)	Smith Helms Mulliss & Moore, L.L.P.	CCW	Class I	1997-05-20
K971231	White River Mini Manual Breast Pump	White River Concepts	HGY	Class I	1997-05-19
K970951	Grass Brainwave Software	Astro-Med, Inc.	OLV	Class II	1997-05-19
K970703	Galileo Halley	Esaote North America, Inc	GWQ	Class II	1997-05-19
K970658	Lumbar Drainage Accessory Kit	Integra Neurocare, LLC	JXG	Class II	1997-05-19
K970645	Bc Thrombin Reagent	Behring Diagnostics, Inc.	GJA	Class II	1997-05-19
K970604	Viewpoint - 3.0 Software	Philips North America LLC	HAW	Class II	1997-05-19
K964825	Freedom Traveller	Impact Case Technologies, Inc.	MLW	Class II	1997-05-19
K963202	Mega Me 3000 Professional Muscle Tester	Mega Electronics, Ltd.	HCC	Class II	1997-05-19
K962753	Kwan Hexagonal Abutment Implant System (Hais)	Biomedical Implant Technology, Inc.	DZE	Class II	1997-05-19
K971524	Total Protein or Tp	Carolina Liquid Chemistries	CEK	Class II	1997-05-16
K971463	Alp Reagent Set	Carolina Liquid Chemistries	CJE	Class II	1997-05-16
K971203	Synchron Systems Thyroxine Reagent	Beckman Instruments, Inc.	KLI	Class II	1997-05-16
K971177	Immulite Vitamin B12 (Lkvb1,lkvb5)	Siemens Healthcare Diagnostics Inc.	CDD	Class II	1997-05-16
K971124	Tm Micro-Catheters	Xomed, Inc.	ETD	Class II	1997-05-16
K970915	Dsl Estrone-Sulfate Ria	Diagnostic Systems Laboratories, Inc.	CGF	Class I	1997-05-16
K970716	Opticon Direct Male Urinary Catheter for Continuous Drainage	Opticon Medical, Inc.	EZL	Class II	1997-05-16
K970659	Dt-24 Telephonic EEG Transmitter/dr-24 Telephonic EEG Receiver	Telediagnostic Systems, Inc.	GYE	Class II	1997-05-16