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 2383 of 3531

510(k) clearances, page 2383 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K914761	Kay-Med Surgical Deape/drap Accessories	Kayco Medical, Inc.	KKX	Class II	1992-04-06
K910463	Merocel(r) Laser-Guard(tm)	Merocel Corp.	BTR	Class II	1992-04-06
K920052	Health Pak Tray Sox Barriers	Healthpak, Inc.	KKX	Class II	1992-04-03
K920044	Dual Lumen Transcerivical Intrauterine Kit	Telos Medical Corp.	KXO	Class II	1992-04-03
K921136	Manual Tilt Chair	Labac Systems, Inc.	IOR	Class I	1992-04-02
K920860	Controlled Passive Motion Machine	U.S. Mfg. & Management, Inc.	BXB	Class I	1992-04-02
K920678	Ultrasound Imagaing System and Doppler Flowmeter	Interspec, Inc.	ITX	Class II	1992-04-02
K920632	Side Firing Fibers	Trimedyne, Inc.	GEX	Class II	1992-04-02
K920625	Lateralase	Trimedyne, Inc.	GEX	Class II	1992-04-02
K920529	Zeiss Multiyag Laser	Carl Zeiss, Inc.	GEX	Class II	1992-04-02
K920463	Zippie 3 Ts/sp Wheelchair/stander	Sunrise Medical Quickie Designs, Inc.	IPL	Class II	1992-04-02
K920374	Aloka 650Cl Diagnostic Ultrasound System	GE Medical Systems Information Technologies, Inc.	IYO	Class II	1992-04-02
K920185	Genesis Electrosurgical Unit	Conmedcorp	GEI	Class II	1992-04-02
K920110	Endopath Disposable Thoracic Trocar Sleeve	Ethicon, Inc	GEA	Class I	1992-04-02
K920060	Dental Solder Alloy	Deringer-Ney, Inc.	EJT	Class II	1992-04-02
K915872	Latex Patient Examination Gloves	Sri Anusham Rubber Industries Pvt., Ltd.	LYY	Class I	1992-04-02
K915852	Accupace Group a Streptococcus Id Test	Hologic, Inc.	MDK	Class I	1992-04-02
K915169	Excel Model Xlt-Two Holmium:yag Laser System	Excel Tech., Ltd.	GEX	Class II	1992-04-02
K915144	Dexter Hand Evaluation and Therapy System	Cedars Medical Center	IKK	Class II	1992-04-02
K915117	Model 1210 Omnipulse Holmium Laser System	Trimedyne, Inc.	GEX	Class II	1992-04-02
K914943	Aqua Med	Aqua Massage Intl., Inc.	ISA	Class I	1992-04-02
K914839	Compel E	Standard Textile Co., Inc.	FYA	Class II	1992-04-02
K914518	Ktp/yag and Ktp/yag Plus	Laserscope	GEX	Class II	1992-04-02
K914335	Strap, Head, Gas Mask	Vital Signs, Inc.	BTK	Class I	1992-04-02
K914329	Surgitron Units- Electro Surg Syst Gyn Indication	Ellman Intl. Mfg., Inc.	HGI	Class II	1992-04-02
K914153	Ott Insufflator Filter Plus/tubing Set	Marlo Surgical Technology	HIF	Class II	1992-04-02
K914006	Biplane Transrectal Probe	Biosound, Inc.	ITX	Class II	1992-04-02
K913300	Laparostat(tm)	Cook Ob/Gyn	HAM	Class II	1992-04-02
K912796	Spore Strip	Raven Biological Laboratories, Inc.	FRC	Class II	1992-04-02
K905200	Saca, 3.5 Mhz Probe	Diasonics, Inc.	ITX	Class II	1992-04-02
K913798	Sonolayer Alpha, Model Ssh-140A	Toshiba America Medical Systems, In.C	ITX	Class II	1992-04-01
K910664	Mod. Trochanter Screw & Washer W/ Anodized Titan.	Medimix Products, Inc.	LWJ	Class II	1992-04-01
K920657	Di Custom in the Ear and in the Canal	Dakota Laboratories, Inc.	ESD	Class I	1992-03-31
K920455	Theraview Digital Portal Imaging Computer (Mod.)	S & S Inficon, Inc.	IYE	Class II	1992-03-31
K920125	Mrt-50 Spine Coil	Toshiba America Mri, Inc.	LNH	Class II	1992-03-31
K920097	Mrt-50 Qd Head Coil	Toshiba America Mri, Inc.	LNH	Class II	1992-03-31
K920089	Monopolar Coagulating Polypectomy Snare	Everest Medical Corp.	KNS	Class II	1992-03-31
K915343	Uresil Laparoscopic Cholangiography Catheter	Uresil, LLC	GCA	Class II	1992-03-31
K914975	Cable Car Sunglasses	Cable Car Sunglasses	HQZ	Class I	1992-03-31
K914465	Autoclavable Version Thera-Mist Nebulizer, P32000	Pegasus Research Corp.	CAF	Class II	1992-03-31
K914140	Grassi Gastrojejun Tube Gastric Decomp/jejun Feed	Bissell Medical Products, Inc.	FPP	Class I	1992-03-31
K912374	Bard(r) Urotack(r) 210 Monitoring System	C.R. Bard Inc	KOC	Class II	1992-03-31
K921122	Soundchoice Bte	Bausch & Lomb Incorporated	ESD	Class I	1992-03-30
K921106	Sterile/single Use Eye Sphere Implants	Storz Instrument Co.	HPZ	Class II	1992-03-30
K921068	Gikter ECG Cassette Tape Recorder Model Xr 300	Datrix LLC	DSH	Class II	1992-03-30
K920753	RF Stat Igm Test Kit	Biowhittaker Molecular Applications, Inc.	DHR	Class II	1992-03-30
K920386	Anti-Ena Antibody Test Kit	Immco Diagnostics, Inc.	LLL	Class II	1992-03-30
K920385	Anti-Ena Antibody Test (Sm)	Immco Diagnostics, Inc.	LLL	Class II	1992-03-30
K920384	Anit-Ena Antibody Test [Ss-B (La)]	Immco Diagnostics, Inc.	LLL	Class II	1992-03-30
K920383	Anti-Ena Antibody Test [Ss-a (Ro)]	Immco Diagnostics, Inc.	LLL	Class II	1992-03-30