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 1649 of 3531

510(k) clearances, page 1649 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K002793	Ketac Cem U	Espe Dental AG	EMA	Class II	2000-09-26
K002770	Ibis Chemo-Port Implantable Vascular Access System, Model 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10	Hdc Corp.	LJT	Class II	2000-09-26
K002541	Protein C Reagent	Siemens Healthcare Diagnostics Inc.	GGP	Class II	2000-09-26
K002461	Hy-Bond Polycarboxylate Temporary Dental Cement	Shofu Dental Corp.	EMA	Class II	2000-09-26
K002360	Cloud Cuff	Parts Port, Ltd.	DXQ	Class II	2000-09-26
K002354	Carbon Dioxide-L3k-C Assay, Models 288-30 and 288-80	Sekisui Diagnostics P.E.I. Inc.	KHS	Class II	2000-09-26
K002302	Super 14	Dental Alloy Products, Inc.	EJH	Class II	2000-09-26
K002300	Super 6	Dental Alloy Products, Inc.	EJH	Class II	2000-09-26
K002285	Atac Pak Alp Reagent Kit	Elan Diagnostics	CJE	Class II	2000-09-26
K002066	Freezer Teether	Cool Baby, Inc.	KKO	Class II	2000-09-26
K002030	Omni-Trak 3150/3155A Series Monitor with Anesthetic Agent, Model 3155A Series	Invivo Research, Inc.	MWI	Class II	2000-09-26
K001970	Jet 1 Powered Wheelchair	Pride Mobility Products Corp	ITI	Class II	2000-09-26
K001647	Bn Prospec System	Siemens Healthcare Diagnostics Inc.	JZW	Class I	2000-09-26
K001244	Blood Pressure Meter, Models Ch-631B, Ch-631D, Ch-632B, Ch-632D	Citizen Watch Co., Ltd.	DXN	Class II	2000-09-26
K001022	Biocheck, Inc. B-2 Microglobin Enzyme Immunoasay Test Kit, Model Bc-1061	BioCheck Inc	JZG	Class II	2000-09-26
K000885	Drx Hba1c - for Prescription Home Use	Metrika, Inc.	LCP	Class II	2000-09-26
K000512	Oscillomitt, Models Cm 1050, Cm 1040, Cm 1030, Cm 1020, Cm 1010	Cas Medical Systems, Inc.	DXQ	Class II	2000-09-26
K000277	Constellation Catheters	Boston Scientific Corporation	MTD	Class II	2000-09-26
K000095	Olympus Sonosurg Trocar Xt3900 System	Olympus Optical Co., Ltd.	LFL	Unclassified	2000-09-26
K002866	Liquichek Blood Gas Plus E Control Level 4, Model 574	Bio-Rad	JJS	Class I	2000-09-25
K002865	Liquichek Blood Gas Plus E Control, Model 576, 577, 578	Bio-Rad	JJS	Class I	2000-09-25
K002414	Phototherapy Lamp 900Iw501je Phototherapy Power Module 900Iw502je	Fisher & Paykel Healthcare, Inc.	LBI	Class II	2000-09-25
K001992	Ilt 0.014 Catheter, Model C114nl2	Intra Luminal Therapeutics, Inc.	DQY	Class II	2000-09-25
K001958	Keystone Medical Schon Xl Soft-Line Double Lument Catheter. Keystone Medical 12 F Duo-Flow and 14F Duo-Flow 400 Xl Cath	Keystone Medical	MPB	Class II	2000-09-25
K001874	Peripherally Inserted Central Catheter	Utah Medical Products, Inc	LJS	Class II	2000-09-25
K000975	Lipidure Rewetting Drops	Nof Corp.	MRC	Class II	2000-09-25
K002659	Mmo-202Nd Three-Axis Hanging Joystick Oil Hydraulic Micromanpulator	Narishige Co., Ltd.	MQJ	Class II	2000-09-22
K002658	Mmo-202N Three-Axis Joystick Oil Hydraulic Micromanipulator	Narishige Co., Ltd.	MQJ	Class II	2000-09-22
K002654	Howmedica Osteonics Shoulder Screw	Howmedica Osteonics Corp	HWC	Class II	2000-09-22
K002653	Mmn-1 Coarse Manipulator	Narishige Co., Ltd.	MQJ	Class II	2000-09-22
K002005	Boluspro Ultra	Marconi Medical Systems, Inc.	JAK	Class II	2000-09-22
K001945	Synthes (USA) Medial Distal Tibia Plates	Synthes (USA) Products LLC	HRS	Class II	2000-09-22
K001941	Synthes Modular Foot System	Synthes (USA) Products LLC	HRS	Class II	2000-09-22
K001937	Medline Electronic Positioning Chair	MEDLINE INDUSTRIES, LP - Northfield	INO	Class II	2000-09-22
K001926	Vascular Graft Tunneler-Standard Curve, Mid Curve, Full Curve, Short Standard Curve, Vascular Graft Tunneler Accessories	Thoratec Laboratories Corp.	DYB	Class II	2000-09-22
K001023	Freedom, Model 4660	Johnson & Johnson Consumer Companies, Inc.	SEJ	Unclassified	2000-09-22
K992465	Sophy Su8 Pressure Adjustable Valve	Sophysa	JXG	Class II	2000-09-21
K002878	Datex-Ohmeda D-Tec Plus Anesthesia Vaporizer	GE Healthcare	CAD	Class II	2000-09-21
K002599	Modification to Acryderm Silver Antimicrobial Wound Dressing, Models 1041, 1042, 1043, 1044, 1045	Acrymed, Inc.	FRO	Unclassified	2000-09-21
K002248	Dinamap Pro 1000 Monitor, Model 1000	Critikon Company, LLC	DXN	Class II	2000-09-21
K002029	Zoll M Series Nibp Option, Model Mseries Nibp Option	ZOLL Medical Corporation	DXN	Class II	2000-09-21
K002004	Zybit	Zymed Medical Instrumentation	DXH	Class II	2000-09-21
K001176	Disposable Microkeratome Blades-Pe	Oasis Medical, Inc.	HNO	Class I	2000-09-21
K000825	4F-7F Medi-Dyne Torq Flow Xlb Angiographic Catheter	Medi-Dyne, Inc.	DQO	Class II	2000-09-21
K994340	Clinical Specular Microscope, Model Hai Cl-1000Xyz	Hai Laboratories, Inc.	HLI	Class II	2000-09-20
K002784	Aloka Ust-5280-5	Aloka Co., Ltd.	ITX	Class II	2000-09-20
K002242	Polestar N-10	Odin Technologies, Ltd.	LNH	Class II	2000-09-20
K001717	Micor Conduction Catheter	Micor, Inc.	BSO	Class II	2000-09-20
K000664	Vigilance Cco/cedv & Vigilance Cco/svo2/cedv Monitors	Baxter Healthcare Corporation	DXG	Class II	2000-09-20
K002837	Bis Engine	Aspect Medical Systems, Inc.	OLW	Class II	2000-09-19