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 2381 of 3531

510(k) clearances, page 2381 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K920733	Stereo Collimator RF-T Series	Shimadzu Medical Systems	IZW	Class II	1992-04-16
K920732	Catherization Ks-50	Shimadzu Medical Systems	IZZ	Class II	1992-04-16
K920727	Ceiling Tube Support Ch-30X	Shimadzu Medical Systems	IYB	Class I	1992-04-16
K920725	Collimator F-20	Shimadzu Medical Systems	IZW	Class II	1992-04-16
K920516	General Purpose Instrument Tray, Sterile, Disposab	Trinity Laboratories, Inc.	KDD	Class I	1992-04-16
K920420	Dura II Penile Prosthesis	Dacomed Corp.	FAE	Class II	1992-04-16
K920327	Daig Fast Cath Transseptal Sheath Introducer	Daig Corp.	DYB	Class II	1992-04-16
K915470	Optima Nuclear Tomography Stystem	General Electric Co.	KPS	Class II	1992-04-16
K920721	Digital Radiography System Idr-2000	Shimadzu Medical Systems	JAA	Class II	1992-04-15
K920676	Rmi Sofclamp	Research Medical, Inc.	DSS	Class II	1992-04-15
K920398	Cepti-Seal Dressing Chng. Kit for Cent. Venous Cat	Medi-Flex Hospital Products, Inc.	FMF	Class II	1992-04-15
K920181	Optical Frame A285, A210, B220, A215, A255, B220,	Kentucky Optical Co.	HQZ	Class I	1992-04-15
K920139	Gleeson Clot-Buster	Conmedcorp	GCI	Class II	1992-04-15
K914686	Thermo-Flow Set	Inhalation Plastics, Inc.	BTT	Class II	1992-04-15
K914461	A-V Impulse System	Novamedix, Ltd.	JOW	Class II	1992-04-15
K912611	Olsen Laparoscopic Instr, Disposable, Single Use	Olsen Electrosurgical, Inc.	GEI	Class II	1992-04-15
K910152	Orion	Pfizer Laser Systems	GEX	Class II	1992-04-15
K920387	Circlexo.3t X-Ray Tube Assembly	Shimadzu Medical Systems	ITY	Class I	1992-04-14
K920215	Instrumentarium Mega4 Ht	Instrumentarium Imaging, Inc.	LNH	Class II	1992-04-14
K915842	Patient Examination Glove	Precious Mountain Ent. Corp.	LYY	Class I	1992-04-14
K915772	Diascan Blood Glucose Monitoring Test Strip	Home Diagnostics, Inc.	CGA	Class II	1992-04-14
K915770	Ultra+ Blood Glucose Test Strip	Home Diagnostics, Inc.	CGA	Class II	1992-04-14
K915632	Paceart Cpts-86/12	Paceart, Inc.	KRE	Class II	1992-04-14
K915110	Flexiflo Over-the-Guidewire Gastrostomy Kit	Abbott Medical	KNT	Class II	1992-04-14
K914235	Asep Surgeons Gown	Baxter Interwoven Offsite	FYA	Class II	1992-04-14
K920722	X-Ray Diagnostic Table Ysf-200-30-90	Shimadzu Medical Systems	IXR	Class II	1992-04-13
K920550	Display Processor - Model Idp5100	Perkins Mfg. Co.	JAA	Class II	1992-04-13
K920434	Atlas 2000 Vascular Road Mapping System	Squires & Assoc., Inc.	IZI	Class II	1992-04-13
K920161	Biomet Nts Femoral Components	Zimmer GmbH	JDI	Class II	1992-04-13
K914908	Quicvage Plus	Autovage	KDH	Class II	1992-04-13
K914859	Bartronix in-Bed Activity Monitor	Bartronix	KMI	Class I	1992-04-13
K914271	Gambro Engstrom Y-Filter with Edith Flex (1500F)	C.G.H. Medical, Inc.	CAN	Class I	1992-04-13
K913987	Or340 Intraoperative Ultrasound Biopsy Needle Guid	Cerenovus, Inc.	ITY	Class I	1992-04-13
K921047	Model 8100 Urodynamics Measuring System	Browne Medical Systems, Inc.	FAP	Class II	1992-04-10
K920992	Profile Plus Urodynamics Measuring Syst, Modified	Browne Medical Systems, Inc.	FAP	Class II	1992-04-10
K920991	Image Pro Urodynamics Measuring Syst, Modification	Browne Medical Systems, Inc.	FAP	Class II	1992-04-10
K920867	Eme Mp3000 Monitoring and Diagnostic Resting ECG	Electro Medical Equipment Co., Inc.	DRX	Class II	1992-04-10
K920584	Sculptured Endostat	Laserscope	GEX	Class II	1992-04-10
K920120	Nd:yag Surgical Laser	Carl Zeiss, Inc.	GEX	Class II	1992-04-10
K920116	Pwb Lumbosacral Spine System	Cross Medical Products, Inc.	KWP	Class II	1992-04-10
K915656	Carbon Dioxide CO2 Laser	Ion Laser Technology	GEX	Class II	1992-04-10
K914826	Akcess-Cath Kit	Akcess Medical Products, Inc.	LFJ	Class II	1992-04-10
K914775	Talley Micro System/talley Ripplebed	Talley Group Ltd.	FNM	Class II	1992-04-10
K914295	Anesthetic Gas Monitor Type 1304, Modified	Bruel & Kjaer	CBQ	Class II	1992-04-10
K914197	Alloy Scalpel Handpieces	L.A.S.E.R., Inc.	GEX	Class II	1992-04-10
K912816	Press 1 Press 2 9220 Updating of the Module	S & W Medico Teknik	DSK	Class II	1992-04-10
K920149	Osteo Ex-Fi-Re	Osteo AG	JEC	Class II	1992-04-09
K914123	Serim Residual Formaldehyde Reagent Strips	Serim Research Corp.	LIF	Class II	1992-04-09
K913541	Neo-Thor Thoracostomy Kit	Intl. Medical Devices, Ltd.	FMF	Class II	1992-04-09
K913540	Pedia-Thor Thoracostomy Kit	Intl. Medical Devices, Ltd.	FMF	Class II	1992-04-09