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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2702 of 3530

510(k) clearances, page 2702 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K882771	Extracorporeal Membrane Oxygenation Catheter	Cook Inc.	DWF	Class II	1988-09-27
K882568	130 Cryo Unit & Assoc. Cryoprobes & Spray	Spembly Medical, Ltd.	GEH	Class II	1988-09-27
K880920	Laser Flare Cell Meter Fc-1000	Kowa Pharmaceuticals America, Inc.	HJO	Class II	1988-09-27
K880756	Model Pm-20A Physiological Monitor	Advanced Medical Systems, Inc.	DQA	Class II	1988-09-27
K875108	Acs Coronary Angioscopic Catheter	Advanced Cardiovascular Systems, Inc.	LYK	Class II	1988-09-27
K883821	Fef(tm) End-Tidal CO2 Detector	Fenem, Inc.	CCK	Class II	1988-09-26
K883555	Sceptor Resistant Gram-Negative Mic/id #80332	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1988-09-26
K883554	Sceptor Pseudomonas Plus Mic/id Panel #80329	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1988-09-26
K883553	Sceptor Resistant Gram-Negative Mic Panel #80331	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1988-09-26
K883552	Sceptor Pseudomonas Plus Mic Panel Cat.# 80328	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1988-09-26
K883550	Sceptor Staphylococcus Mic #80324	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1988-09-26
K883549	Sceptor Streptococcus Mic Panel #80322	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1988-09-26
K883548	Sceptor Streptococcus Mic/id Panel #80323	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1988-09-26
K883346	Simpson Peripheral Atherocath W/addit. Size 13F	Devices for Vascular Intervention, Inc.	LIT	Class II	1988-09-26
K883332	Mast for Basic Heater-Cooler Unit 16-09-00	Shiley, Inc.	DTR	Class II	1988-09-26
K883331	Basic Heater-Cooler Unit W/mast, 115/110V 16-21-10	Shiley, Inc.	DTR	Class II	1988-09-26
K883330	Basic Heater-Cooler Unit, 115/100V 16-02-20	Shiley, Inc.	DTR	Class II	1988-09-26
K883201	Vital-Vue Illumination, Suction & Irrigation Sys	Vital Metrics, Inc.	HBI	Class II	1988-09-26
K883135	Pti Heart-Lift(tm) Cardiac Elevator (Sterile)	Pioneering Technologies, Inc.	DWS	Class I	1988-09-26
K883054	Scimed Ultrox True Membrane Oxy. Ultrox I & II	Scimed Life Systems, Inc.	DTZ	Class II	1988-09-26
K883053	Scimed Membrane Oxygenator, Model 0600-2A	Scimed Life Systems, Inc.	DTZ	Class II	1988-09-26
K882969	Vascular Access Port/catheter No.vp-Xxx Vasport	Gish Biomedical, Inc.	DQY	Class II	1988-09-26
K882441	Slt Contact Laser System Endophotocoagulation	Surgical Laser Technologies, Inc.	HQB	Class II	1988-09-26
K882315	Vir-a-Vac Empty	Viratec Corp.	GAZ	Class II	1988-09-26
K881851	Veripoid 50 Bio-Electrical Impedance Meter	Micro Medical, Ltd.	DSB	Class II	1988-09-26
K881632	Flowtron Dvt System Ac500 Pump, L501 Garment	Huntleigh Technology, Inc.	JOW	Class II	1988-09-26
K881416	Myotrac	Thought Technology Ltd.	HCC	Class II	1988-09-26
K881402	629V Spirometer, Pulmonary Function Analyzer	American Electromedics Corp.	BZG	Class II	1988-09-26
K880416	Wccs 800 Wallach Cardiac Cryosurgical System	CooperSurgical, Inc.	GEH	Class II	1988-09-26
K883686	Sterile Empty Glass Vials	Farris Laboratories, Inc.	LDH		1988-09-23
K883638	Safesite Injection Site and Blunt Cannula	Baxter Healthcare Corporation	FPA	Class II	1988-09-23
K882871	Casf Drill Guide Dg 170	Terray Manufacturing, Inc.	LYQ	Class I	1988-09-23
K882800	Coltene President Jet Regular Body	Coltene, Inc.	ELW	Class II	1988-09-23
K882427	Cardiac Pace. Opus 4000 Models 4043/4044/4063/4066	Ela Medical, Inc.	DXY	Class III	1988-09-23
K882310	Dual-Temp(tm) Cooling/warming Unit	Seabrook Medical Systems, Inc.	ILO	Class II	1988-09-23
K882167	Ivy Commander, Model 600	Ivy Medical, Inc.	LDR	Class II	1988-09-23
K880475	Skema (Dental Unit)	Alpine Dental Equipment Co.	KLC	Class I	1988-09-23
K880474	Area (Dental Chair)	Alpine Dental Equipment Co.	KLC	Class I	1988-09-23
K874688	Flowtron Ac200/2	Huntleigh Technology, Inc.	IRP	Class II	1988-09-23
K883715	Axial Compression Screw	Straub Clinic and Hospital	KTT	Class II	1988-09-22
K883712	Qm300 Control F Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DFC	Class II	1988-09-22
K883711	Qm300 Calibrator F Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DFC	Class II	1988-09-22
K883616	Specific Allergen Modules for Alastat(tm)	Siemens Healthcare Diagnostics Inc.	DHB	Class II	1988-09-22
K883588	Compeed Athletic Dressing	MEDLINE INDUSTRIES, LP - Northfield	FRO	Unclassified	1988-09-22
K883518	Event Marker & a Second Pressure Trend Output	Metatech Corp.	GWM	Class II	1988-09-22
K883515	Du Pont Dimension C-Reactive Protein Method	E.I. Dupont de Nemours & Co., Inc.	DCN	Class II	1988-09-22
K883509	Heraeus Dg 63	Degussa Dental, Inc.	EJS	Class II	1988-09-22
K883508	Hera H	Degussa Dental, Inc.	EJT	Class II	1988-09-22
K883493	Technicon Dpa-1 Immunoglobulin M	Technicon Instruments Corp.	DFL	Class II	1988-09-22
K883492	Technicon Dpa-1 Immunoglobulin a	Technicon Instruments Corp.	CZP	Class II	1988-09-22