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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3334 of 3528

510(k) clearances, page 3334 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K801965	Custom Universal Cutdown Prep Tray	American Pharmaseal Div. Ahsc	FSM	Class I	1980-10-10
K801964	Custom Lymphangiogram Acces. Pack-Steri	American Pharmaseal Div. Ahsc	FSM	Class I	1980-10-10
K801961	RF-II Test Kit	Immuno-Diagnostic Products, Inc.	DHR	Class II	1980-10-10
K801960	Anti-Ds/n-DNA Test Kit	Immuno-Diagnostic Products, Inc.	DBL	Class II	1980-10-10
K801898	Uric Acid Diagnostic Reagent	Connecticut Diagnostics, Ltd.	KNK	Class I	1980-10-10
K801897	Glucose Diagnostic Reagent	Connecticut Diagnostics, Ltd.	CGA	Class II	1980-10-10
K801884	Op-Site Skin Closure Suture Adhesive	Acme United Corp.	FPX	Class I	1980-10-10
K801881	Inpersol-Capd Administration Set	Abbott Medical	KDJ	Class II	1980-10-10
K801860	S.s. White-Pennwalt Renew Calcium Hydrox	Pennwalt Corp.	EJK	Class II	1980-10-10
K801841	Fibrin(ogen) Degradation Products(fdp)	American Hospital Supply	GHH	Class II	1980-10-10
K801815	Autolet	Ulster Scientific, Inc.	JCA	Class II	1980-10-10
K801775	Sero Strep Kit	Sacks Farms Biological Products	GTZ	Class I	1980-10-10
K801517	Bed Rocking Device	Wesler	FNJ	Class I	1980-10-10
K802422	Hycel Trigyceride II Test	Hycel, Inc.			1980-10-06
K802329	Disposable Constrast Delivery Spike Kit	Stanco Medical, Inc.	FPA	Class II	1980-10-03
K802323	Pediatric Oxygen or Aerosol Masks,	Airlife, Inc.	BYG	Class I	1980-10-03
K802296	Mingograf Eeg10	Siemens Corp.	GWQ	Class II	1980-10-03
K802292	Mingograf Eeg21	Siemens Corp.	GWQ	Class II	1980-10-03
K802285	Ohio Thoracic Suction Regulator	Ohio Medical Products	KOP	Class I	1980-10-03
K802281	Sherwood Nano-Mist Nebulizer W/mouthpiec	Sherwood Medical Co.	CCQ	Class I	1980-10-03
K802273	Telemetry Transmitter, #Tlt-3	BD Becton Dickinson Vacutainer Systems Preanalytic	DRG	Class II	1980-10-03
K802270	Protective Bar for the Ma-1Ventilator	Eastern Anesthesia, Inc.	CBK	Class II	1980-10-03
K802261	Pressure Gauge Accessory Kit/dilatation	Stanco Medical, Inc.	DWF	Class II	1980-10-03
K802252	Hot Cycle, a Chemical Type Hot Pack	Signal West	IMD	Class I	1980-10-03
K802244	Vessel Retractor, #600732	Bentley Laboratories, Inc.	DXC	Class II	1980-10-03
K802237	Corrosion Proof Dual Purpose ECG Wires	Custom Cardio Components	DSA	Class II	1980-10-03
K802236	Corrosion Proof Snap ECG Connect Wires	Custom Cardio Components	DSA	Class II	1980-10-03
K802205	Ecg/respiration Stimulator	Healthdyne, Inc.	BZQ	Class II	1980-10-03
K802204	CT-1600 Digital Pulse Rate Monitor	Industrial & Biomedical Sensors Corp.	DRT	Class II	1980-10-03
K802203	Cm-700A Auto-Inflate Control Module	Industrial & Biomedical Sensors Corp.	DXN	Class II	1980-10-03
K802118	Bear 2 Adult Vol. Ventilator	Bourns Medical Systems, Inc.	CBK	Class II	1980-10-03
K802116	Anesthesia Gas Machine	Medtronic, Inc.	BZC	Class II	1980-10-03
K802107	Egs #300 Battery Oper. Porta. Muscle Sti	Electro-Med Health Industries, Inc.	IPF	Class II	1980-10-03
K802087	Babybird 2 Ventilator	Bird Products Corp.	CBK	Class II	1980-10-03
K802063	Spembly 9000 & 9300	Spembly Medical, Ltd.	GZJ	Class II	1980-10-03
K802051	Newbourns Infant Ventilator	Bourns Medical Systems, Inc.	CBK	Class II	1980-10-03
K802030	U.i. Octoson	Ausonics Pty, Ltd.	DXK	Class II	1980-10-03
K801950	Bcm-600 Mini-Six Extra Lg. Field Angio	B C Medical, Ltd.	KPX	Class II	1980-10-03
K801949	Bcm-302 Collimating Cone & Compensatin	B C Medical, Ltd.	JZW	Class I	1980-10-03
K801925	Cabanna Tan Sunlamp	The Marketing Exchange, Inc.	LEJ	Class II	1980-10-03
K801920	System 80 Computerized Spirometer	Pulmonary Testing Systems	BZC	Class II	1980-10-03
K801919	System 88 Computerized Diffusion Analy	Pulmonary Testing Systems	BZC	Class II	1980-10-03
K801918	System 82 Computerized Lung Vo. Spiro	Pulmonary Testing Systems	BZC	Class II	1980-10-03
K801844	Sonia-So Nograph-Numerical Analysis	Cgr Medical Corp.	IYO	Class II	1980-10-03
K801679	Beta-Cap II	Quinton, Inc.	FJS	Class II	1980-10-03
K801640	Sorin Pulse Generator, Model #Lit-214	Bentley Laboratories, Inc.	DXY	Class III	1980-10-03
K801603	Polyethylene Filled Bone Plate	Zimmer GmbH	HRS	Class II	1980-10-03
K801585	Hessburg-Bfrron Trephine	Precision Instruments, Inc.	EMF	Class I	1980-10-03
K801497	Infant Ventilatory Measurement System	Medical Graphics Corp.	BZC	Class II	1980-10-03
K801456	F/ls Mca Application Software	Instrumentation Laboratory Co.	CFR	Class II	1980-10-03