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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3431 of 3526

510(k) clearances, page 3431 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K781568	Pacemaker, Model 251-01	Intermedics, Inc.			1978-10-18
K781681	Phipiological Synchronizer Part#205	Brattle Instrument Corp.	IXQ	Class II	1978-10-17
K781676	X-Ray Stand, Portable	General X-Ray, Inc.	IZL	Class II	1978-10-17
K781673	Maxi-Camera 535	General Electric Co.	IYX	Class I	1978-10-17
K781661	Thermometer, Digital Elec. Model 4755	British Aerospace, Inc.	FLL	Class II	1978-10-17
K781658	Projector, Accu-Chart Acuity	Bausch & Lomb Incorporated	HOS	Class I	1978-10-17
K781650	Terry Keratometer	Clifford M. Terry, M.C.	HJA	Class I	1978-10-17
K781647	Back Trac	Tech Engineering, Inc.	HST	Class I	1978-10-17
K781607	Strep-Tex	Burroughs Wellcome Co.	GTZ	Class I	1978-10-17
K781599	I-Estriol Test Set	Wien Laboratories, Inc.	CGI	Class I	1978-10-17
K781598	Technicon Autoslide Staining/processing	Technicon Instruments Corp.	KPA	Class I	1978-10-17
K781593	Ria Controls	Dade, Baxter Travenol Diagnostics, Inc.	JJY	Class I	1978-10-17
K781581	Surgical Light 22 Series	American Sterilizer Co.	FQP	Class II	1978-10-17
K781573	Abnormal Hematology Control Unassayed	Ortho Diagnostics, Inc.	JPK	Class II	1978-10-17
K781572	Normal Hematology Control Unassayed	Ortho Diagnostics, Inc.	JPK	Class II	1978-10-17
K781560	Ria Diag. Test Kit for Indexing Thyrox.	Nuclear Diagnostics, Inc.	CEC	Class II	1978-10-17
K781557	24-Hour Urine Collection Cooling Wrap	Sage Products LLC	FMH	Class I	1978-10-17
K781556	Pressure Infusion Cuff	Abbott Medical	DXN	Class II	1978-10-17
K781548	Umbilical Cord Clamp	Hollister, Inc.	HFW	Class II	1978-10-17
K781529	Septal Button	Xomed, Inc.	LFB	Unclassified	1978-10-17
K781524	Maxiray 125 Tube Unit	General Electric Co.	ITY	Class I	1978-10-17
K781514	ECG Electrode, 2021, 2022, 2032, 2033	Cardio-Dynamics Laboratories, Inc.	DRX	Class II	1978-10-17
K781506	Mic-Bio-Plate	Pasco Laboratories, Inc.	JSF	Class I	1978-10-17
K781382	Emit Procainamide Assay	Syva Co.	LAR	Class II	1978-10-17
K781364	Pint Bottle Well	Baxa Corp., Sub. of Cook Group, Inc.	KYX	Class I	1978-10-17
K781354	Pillows- Single Patient Use	Abco Dealers, Inc.	KME	Class I	1978-10-17
K781350	Objects Precision Handling Test Kit	Metro. Hospital & Health Center	ION	Class I	1978-10-17
K781227	Towels, Sheets, Pillowcases	Abco Dealers, Inc.	KME	Class I	1978-10-17
K781153	Kidney, Artificial	BD Becton Dickinson Vacutainer Systems Preanalytic	DJC	Class II	1978-10-17
K781102	Dialyzer, Disp., Coil, Lundia	Gambro, Inc.	FHS	Class II	1978-10-17
K780721	Identi-Clamps	Berkeley Bio-Medical, Inc.	GDJ	Class I	1978-10-17
K780720	Identi-Loops	Berkeley Bio-Medical, Inc.	GAD	Class I	1978-10-17
K781591	Nebulizer/humidifier Model Eh 147B	Mistogen Equipment Co.	KFZ	Class I	1978-10-16
K781485	Patient Circuit Manifold	Bourns Medical Systems, Inc.	CAF	Class II	1978-10-16
K781394	Disposable Incentive Spirometer	Inhal-O-Tech Medical Plastic	CCQ	Class I	1978-10-16
K781300	Oxygen Concentrator	Bendix Instruments & Life Support Div	CAW	Class II	1978-10-16
K781224	Meter, Flow, Peak	Projects in Health	BZH	Class II	1978-10-15
K781166	Monitor, Heart Rate	Cybernetic Medical, Inc.	DRT	Class II	1978-10-15
K781683	Nurite II, Single	Bio-Medical Systems Corp.	GZJ	Class II	1978-10-13
K781271	Monitor, Po2, Intravascular	Roche Medical Electronics, Inc.	CCE	Class II	1978-10-12
K781636	c.p.r. Counting Pacer	Qual-Tec, Inc.			1978-10-11
K781615	Nasostat	Nasostat, Inc.	EMX	Class I	1978-10-11
K781580	Perfit Dental Restorative Composite	Locite Corp.	EBF	Class II	1978-10-11
K781565	Electrical Nerve Stimulator Model 6035	Stimulation Technology, Inc.	GZJ	Class II	1978-10-11
K781554	Rad-291	Organon LLC	JQX	Class I	1978-10-11
K781487	Early Pregnancy Detection Kit	Radioassay Systems Laboratories, Inc.	JHI	Class II	1978-10-11
K781412	Oscillating Knife and Accessories	Cerenovus, Inc.	HMY	Class I	1978-10-11
K781663	Hearing Aid, Ite Modular Model I, II, V	Oticon, Inc.	ESD	Class I	1978-10-10
K781642	Ra-I	Diasonics, Inc.	IYN	Class II	1978-10-10
K781631	Echo-Oil	Echo Laboratories, Inc.	EMX	Class I	1978-10-10