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 2251 of 3531

510(k) clearances, page 2251 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K932036	Laceration Tray	Clinipad Corp.	FRG	Class II	1993-12-13
K931747	Fever Monitoring Kit	Polymedica Healthcare, Inc.	FLL	Class II	1993-12-13
K926315	Practice Partner	Rs Imaging	LMD	Class I	1993-12-13
K924851	Strato Medical Single Lumen Valved Catheter	Strato Medical Corp.	LJS	Class II	1993-12-13
K923697	Radionuclide Catheters, Rnc-a, Rnc-G, Rnc-U	Radionics, Inc.	KXK	Class II	1993-12-13
K923484	Steri-Oss Titanium Screw Series Implant	Steri-Oss, Inc.	DZE	Class II	1993-12-13
K920421	Medsurg Marshmallow Tray	Medsurg Industries, Inc.	GAT	Class II	1993-12-13
K914793	Monocrystant Ph/les Catheter, Modification	Synectics-Dantec	KLA	Class II	1993-12-13
K935390	Sirolux Fantastic	KaVo Dental Technologies, LLC	EAZ	Class I	1993-12-10
K934978	Fermit N Light-Curing Temporary Filling Material	Ivoclar North America, Inc.	EBG	Class II	1993-12-10
K934970	Duet	Trulife, Inc.	GBJ	Class I	1993-12-10
K934951	Valve Sizer	Carbomedics, Inc.	DTI	Class I	1993-12-10
K934773	Argelite a	Argen Precious Metals, Inc.	EJS	Class II	1993-12-10
K934768	Argelite 81Sf+	Argen Precious Metals, Inc.	EJH	Class II	1993-12-10
K934760	Immunlite Intact Pth	Siemens Healthcare Diagnostics Inc.	CEW	Class II	1993-12-10
K934562	Ciba Corning Acs Testosterone Immunoassay	Ciba Corning Diagnostics Corp.	CDZ	Class I	1993-12-10
K934283	Dentalon Plus Modification	Kulzer GmbH	EBG	Class II	1993-12-10
K933894	Disposable Perforator	Cerenovus, Inc.	HBF	Class II	1993-12-10
K933703	Sigma Wash Concentrate Solution	Sigma Chemical Co.	JJE	Class I	1993-12-10
K933668	Almost U, Inc. Breast Prosthesis	Almost U., Inc.	KCZ	Class I	1993-12-10
K932766	Hdl-Cholestral(dextran Sulfate/magnesium)	Diagnostic Chemicals, Ltd. (USA)	LBR	Class I	1993-12-10
K932676	Spyrofilm Iq Wound Dressing(with Inert Filler)	Polymedica Industries, Inc.	FRO	Unclassified	1993-12-10
K931962	Non-Absorbable Gauze	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1993-12-10
K931618	Duoderm Hydrocolloid Gel	Convatec, A Division of E.R. Squibb & Sons	NAE	Class I	1993-12-10
K924420	Medical Disposable Bedding	Hill-Rom Inc.	KNC	Class II	1993-12-10
K924184	Cvi-Q(tm) Option for P700	Philips North America LLC	IYO	Class II	1993-12-10
K924121	Steri-Oss Screw Style Itianium Implant	Steri-Oss, Inc.	DZE	Class II	1993-12-10
K923695	Steri-Oss Screw Style Cp Titanium Implant	Steri-Oss, Inc.	DZE	Class II	1993-12-10
K912355	Mothers Touch One Hand Breast Pump	Hollister, Inc.	HGY	Class I	1993-12-10
K935183	Emds Magnesium (Mg) Test	Em Diagnostic Systems, Inc.	JGJ	Class I	1993-12-09
K935182	Emds Alkanine Phosphatase (Alp) Test	Em Diagnostic Systems, Inc.	CJE	Class II	1993-12-09
K934961	Spinpro Hdl Precipitating Reagent	Merchant House Scientific	LBR	Class I	1993-12-09
K934641	I-Stat Control Levels 1,2,3	I-Stat Corp.	JJR	Class I	1993-12-09
K934433	Vantage Dialtaion Catheter	Peripheral Systems Group	LIT	Class II	1993-12-09
K934339	Loc Guide Wire Extension	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1993-12-09
K934191	New Blue Max Balloon Dilatation Catheter	Boston Scientific Corporation	LIT	Class II	1993-12-09
K933897	Phx Technologies Corp., 5Mm Disposable Suction-Irrigation Cannula Cleaner	Phx Technologies Corp.	GCJ	Class II	1993-12-09
K933896	Phx Technologies Corp., Monopolar Electrocautery Probe Tip Cleaner	Phx Technologies Corp.	GCJ	Class II	1993-12-09
K933692	Sigma CO2 Acid Reagent	Sigma Chemical Co.	JFL	Class II	1993-12-09
K932846	Tencel X-Ray Detectable Sponges/lap Pads	Courtaulds Fibers, Inc.	GDY	Class I	1993-12-09
K932623	Quantimetrix Blood Glucose Controls	Quantimetrix Corp.	JIX	Class II	1993-12-09
K932418	Sunbronze Tanning Lamps	Ess Lighting	LEJ	Class II	1993-12-09
K932321	Laparoscopy Optics	MEDLINE INDUSTRIES, LP - Northfield	GCJ	Class II	1993-12-09
K931965	Medix Phototherapy Lamp	Medix I.C.S.A.	LBI	Class II	1993-12-09
K925325	A-Dec 2185 Doctor's Unit	A-dec, Inc.	KLC	Class I	1993-12-09
K925324	A-Dec 2184 Duo Unit	A-dec, Inc.	KLC	Class I	1993-12-09
K925323	A-Dec 2183 Duo Unit, Cusp	A-dec, Inc.	KLC	Class I	1993-12-09
K925322	A-Dec 2147 Doctor's Unit	A-dec, Inc.	KLC	Class I	1993-12-09
K925321	A-Dec 2146 Duo Unit	A-dec, Inc.	KLC	Class I	1993-12-09
K925320	A-Dec 2145 Duo Unit, Cusp	A-dec, Inc.	KLC	Class I	1993-12-09