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 2026-11-02, 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 2417 of 3531

510(k) clearances, page 2417 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K914302	Gen-X 800/650	Swissray Finatech, Inc.	IZO	Class I	1991-10-30
K914301	Gen-X 800/800	Swissray Finatech, Inc.	IZO	Class I	1991-10-30
K914179	Cardiofocal Collimator	Siemens Gammasonics, Inc.	KPS	Class II	1991-10-30
K914120	Single Use Laparoscopy Electrosurgical Instrument	Conmedcorp	GCI	Class II	1991-10-30
K914095	Peepers Tanning Goggles	California Suncare, Inc.	HOY	Class I	1991-10-30
K914040	Phospholipid Reagent Set	Sterling Diagnostics, Inc.	JNT	Class I	1991-10-30
K914034	Infucare Syringe Pump Tubing Set	Infucare Products, Inc.	FRN	Class II	1991-10-30
K913992	Aspiration/injection Needle	Northgate Technologies Inc.	GAA	Class I	1991-10-30
K913884	Fuji II Lc	G-C Intl. Corp.	EMA	Class II	1991-10-30
K913815	Automated Biopsy Device, Modification	Hart Enterprises, Inc.	DWO	Class I	1991-10-30
K913782	Tcal Abutment	Core-Vent Corp.	DZE	Class II	1991-10-30
K913757	Hologic Cer 20/20, Computed Equal Radio Diag Chest	Hologic, Inc.	KPR	Class II	1991-10-30
K913720	Pancretec Provider One Infusion System, Modified	Abbott Medical	FRN	Class II	1991-10-30
K913719	Pancretec i.v. Model 5500 Infuser	Abbott Medical	FRN	Class II	1991-10-30
K913718	Pancretec i.v. Model 5000 Infus Device, Modified	Abbott Medical	FRN	Class II	1991-10-30
K913652	Coffman Tomograph	Coffman Dental	EHD	Class II	1991-10-30
K913489	Siemens Micro2 Pulse Oximeter	Siemens Medical Electronics	DQA	Class II	1991-10-30
K913475	Magnetic Resonance Diagnostic Device	GE Healthcare	LNH	Class II	1991-10-30
K913058	Rep(tm) Spe Temp-30-16-8 Procedure, 3170,3171,3172	Helena Laboratories, Corp.	CEF	Class I	1991-10-30
K912997	Miniflex and Personal Unit	Dabi-Atlante America Corp.	EAZ	Class I	1991-10-30
K912910	C100 Infant Incubator Shelf/mount Rail System	Air-Shields Vickers, Inc.	FMZ	Class II	1991-10-30
K912331	Urs-Hydro-Dilator Model Number 2164.00	Richard Wolf Medical Instruments Corp.	EZN	Class II	1991-10-30
K912142	Micronaire ISO-Hood Max 5Uv	Micronaire Corp.	EAZ	Class I	1991-10-30
K912030	Cdi(tm) 2000 Blood Gas Monitoring Syst, Modified	3M Company	CBZ	Class II	1991-10-30
K911975	Smt-100X	Shimadzu Medical Systems	LNH	Class II	1991-10-30
K911315	Extracorporeal Blood Pumping Syst for Hemofiltrat	Baxter Healthcare Corporation	KOC	Class II	1991-10-30
K913415	Aesculap Titanium Bone Screws	Aesculap Inc	HWC	Class II	1991-10-29
K914553	Action Series Manual Wheelchairs, Various Models	Invacare GmbH	IOR	Class I	1991-10-28
K914388	C1 Rid Kit	The Binding Site	DAK	Class II	1991-10-28
K914098	Laparoscopic Mini-Dissector/right Angle Retractor	Surgical Innovations Ltd	GCJ	Class II	1991-10-28
K914094	Dermasafe(th) Hypoallergenic	Multi-Com Sdn Bhd	LYY	Class I	1991-10-28
K914090	Daig Fast Cath(tm) Introducer, Modification	Daig Corp.	DYB	Class II	1991-10-28
K913762	Monoscopy(tm) Brand, Endobag	Dexide, Inc.	GCJ	Class II	1991-10-28
K913760	Psoralite , Phototherapy Treatment Equipment	Psoralite Corp.	FTC	Class II	1991-10-28
K913631	.014 Hi-Torque Floppy Pathfinder Guide Wire	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1991-10-28
K913416	Tetley Patient Administration Set	Tetley Medical, Ltd.	IYT	Class II	1991-10-28
K913405	Kar-D-Tek	Gresco Products, Inc.	LFC	Class II	1991-10-28
K913080	Opus(r) Anti Cmv-M	Pb Diagnostics, Inc.	LKQ	Class II	1991-10-28
K912987	Crystal Focus Emer Laser Photo Vis Red Oper Mode	Douglas James Donaldson Compliance Services	GEX	Class II	1991-10-28
K912897	Sceptor Identification System	BD Becton Dickinson Vacutainer Systems Preanalytic	LQM	Class I	1991-10-28
K912604	Sjm/cad Isoflow(tm) Centrifugal Pump 2100Cp, Modif	Aries Medical, Inc.	KFM	Class II	1991-10-28
K912573	Vision (Nuclear Medicine Computer)	Summit Nuclear	KPS	Class II	1991-10-28
K912014	Tbd, Empi Buffered Iontophoresis Electrodes Mdl. 2	Empi	EGJ	Class II	1991-10-28
K911965	Electronic Digital Blood Pressure/pulse Monitor	Citizen Watch Co., Ltd.	DXN	Class II	1991-10-28
K911251	Flex-IV	Medway	FOZ	Class II	1991-10-28
K910778	Steam Vacuum Pulse Sterilizer System (Svpss)	Mdt Biologic Co.	FLE	Class II	1991-10-28
K914485	Ventilator Stand	Bird Products Corp.	CBK	Class II	1991-10-25
K914466	Cox Disposable Cytology Brushes	Cox Medical Ent., Inc.	FDX	Class II	1991-10-25
K914442	Cox Disposable Endoscope Cleaning Brush	Cox Medical Ent., Inc.	FEB	Class II	1991-10-25
K914240	Clearview Hcg Serum/urine Profess Preg Test, Modif	Unipath, Ltd.	JHI	Class II	1991-10-25