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 2026-10-21, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2995 of 3529

510(k) clearances, page 2995 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K851552	Merivaara Hospital Bed	Daun International, Inc.	FNJ	Class I	1985-05-08
K851551	Merivaara Electric Hospital Bed & Accessories	Daun International, Inc.	FNL	Class II	1985-05-08
K851447	Ivac Model 580 Gener. Use Volumetric Infusion Pump	Y	FRN	Class II	1985-05-08
K851384	Medical/surgical Suction System	Medtronic, Inc.	GCX	Class II	1985-05-08
K851360	Imed Graviset Intravascular Admin. Set	Imed Corp.	FRN	Class II	1985-05-08
K851316	Abco Suction Canister	Abco Dealers, Inc.	KDQ	Class II	1985-05-08
K850486	General Diag. Chromostrate Heparin Assay	Warner-Lambert Co.	KFF	Class II	1985-05-08
K850412	Gen. Diag. Chromostrate Antithrombin III Assay	Warner-Lambert Co.	JBQ	Class II	1985-05-08
K850411	Gen. Diag. Chromostrate Alpha-2 Antiplasmin Assay	Warner-Lambert Co.	LGP	Class II	1985-05-08
K850410	Gen. Diag. Chromostrate Plasminogen Assay	Warner-Lambert Co.	DDX	Class I	1985-05-08
K850409	Gen. Diag. Chromostrate Ref. Plasma	Warner-Lambert Co.	JPA	Class II	1985-05-08
K851690	Adjustable Treatment Tables	I-Rep, Inc.			1985-05-07
K851532	Suntanning Equipment	Oakport Intl., Inc.	FTC	Class II	1985-05-07
K851480	Vygon Guedel Airway 511 Vygon Bermann/orophar Airw	Vygon Corp.	LAE	Class II	1985-05-07
K851478	Vygon Spinal Anesthesia Needle W/introducer 183	Vygon Corp.	BSP	Class II	1985-05-07
K851474	Vygon Spinal Anesthesia Tray Code No. 190	Vygon Corp.	LAZ	Class I	1985-05-07
K851395	Sandare Iron-Binding Capacity Procedure	Sandare Chemical Co., Inc.	JMO	Class I	1985-05-07
K851361	Amerlex-M Follicle Stimulating Hormone(fsh)radioim	Amersham Corp.	CGJ	Class I	1985-05-07
K851299	Correct Flo	Norton Performance Plastics Corp.	FPA	Class II	1985-05-07
K851017	Quest 521 Variable Pressure Volumetric Infusion Pu	Quest Medical, Inc	FRN	Class II	1985-05-07
K850993	Smart Alex II Multi-Filter Photometer	Awareness Technology, Inc.	JJQ	Class I	1985-05-07
K850888	Percutaneous Cv Catheter Insertion Kit W or W/o Cv	Creative Care Systems, Inc.	LJT	Class II	1985-05-07
K850819	Geliperm Absorbind Granulated Gel	Geistlich Pharma AG	FRO	Unclassified	1985-05-07
K850453	Sinus Ac-Powered Muscle Stimulator	Zimmer Elektromedizin GmbH	IPF	Class II	1985-05-07
K850282	Hypafix Post Operative Dressing	Smith & Nephew, Inc.	NAD	Class I	1985-05-07
K844390	Escotek-Est 204 Multi Stim	Nor-Am Patient Care Products, Inc.	IPF	Class II	1985-05-07
K844389	Escotek Est 210, High Voltage Electro Galvanic Sti	Nor-Am Patient Care Products, Inc.	IPF	Class II	1985-05-07
K844388	Escotek Est 220 Interference Therapy Unit	Nor-Am Patient Care Products, Inc.	IPF	Class II	1985-05-07
K844387	Escotek-Est 221 Vacuum Unit	Nor-Am Patient Care Products, Inc.	IPF	Class II	1985-05-07
K850455	Quantix Cardiac Angiographic System	Xre Corp.	IZI	Class II	1985-05-06
K844664	The i.v. Bag	Kabivitrum, Inc.	KPE	Class II	1985-05-06
K851706	Universal Computer Interface System	Vacumetrics, Inc.	BZM	Class II	1985-05-03
K851656	Shoulder Traction Kit	Chattanooga Group, Inc.			1985-05-03
K851612	Derma Prep	Mowbray Co., Inc.	KGT	Class I	1985-05-03
K851487	Codman Disposable Bipolar Card	Cerenovus, Inc.	GEI	Class II	1985-05-03
K851477	Vygon Exchange Transfusion Tray 275.00	Vygon Corp.	BRZ	Class II	1985-05-03
K851475	Vygon Cannula for Surgical Suction Yan Kauer 574/5	Vygon Corp.	GBX	Class I	1985-05-03
K851443	Micro-Aire Oscillating Saw, 1740-000 & Wire Driver	Micro-Aire Surgical Instruments, Inc.	HSZ	Class I	1985-05-03
K850912	Sterile Disposable Pn Drape System	Brant-Wald Surgicals, Inc.	KKX	Class II	1985-05-03
K851583	Hektoen Enteric Agar	Preferred Micro-Media	JSI	Class I	1985-05-02
K851582	Gn Broth	Preferred Micro-Media	JSJ	Class I	1985-05-02
K851581	Dermatophyte Test Medium	Preferred Micro-Media	JSI	Class I	1985-05-02
K851580	Columbiz Cna Agar W/5% Sheep Blood	Preferred Micro-Media	JSJ	Class I	1985-05-02
K851172	Cobas Mira	Roche Diagnostic Systems, Inc.	JJF	Class I	1985-05-02
K850864	Tracheobronchial Suction Kits W/catheters Eto	Paco Research Corp.	BSY	Class I	1985-05-02
K850773	Pm Cementless Screw-in Acetabular Cup	Advanced Biosearch Assn.	KWA	Class III	1985-05-02
K850600	Co-Ax Ventilator Circuit	Nova-Ventrx	BZO	Class I	1985-05-02
K850536	Quickie Wheelchairs	Motion Designs, Inc.	IOR	Class I	1985-05-02
K850386	System 8000 Cell Counter	Baker Instructions Corp.	GKL	Class II	1985-05-02
K845022	Patho Dx Latex Agglutination Strep B Kit	Siemens Healthcare Diagnostics Inc.	GTZ	Class I	1985-05-02