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 3379 of 3526

510(k) clearances, page 3379 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K792332	Davol/simon Dermatome	Davol, Inc.	GFD	Class I	1979-12-06
K792330	Xomed Microsurgery Background	Xomed, Inc.			1979-12-06
K792319	Coulter Hdl Cholesterol Reag. System	Coulter Electronics, Inc.	LBS	Class I	1979-12-06
K792314	Rid Systems - Alph-1-Acid Glycoprotein	Icl Scientific	FAM	Class II	1979-12-06
K792308	Concep-7-Bhcg	Leeco Diagnostics, Inc.	JHI	Class II	1979-12-06
K792292	Ames Dextrometer Reflectance Colorimeter	Miles Laboratories, Inc.	JJQ	Class I	1979-12-06
K792291	Synthes Reconstructive Plates 'Y' Plates	Synthes (USA) Products LLC	KTW	Class II	1979-12-06
K792290	Tsh Standards & Diluent	Amersham Corp.	JIT	Class II	1979-12-06
K792285	Technicon C800 System	Technicon Instruments Corp.	JJC	Class I	1979-12-06
K792279	Autopak 12 Insulin Test Delivery System	Micromedic Systems	CFP	Class I	1979-12-06
K792256	Keithley Clamp	Keithley Development Co.	EYR	Class I	1979-12-06
K792254	Nova 3+3 Chloride/total Carbon Dioxide	Nova Biomedical Corporation	JFL	Class II	1979-12-06
K792243	Centria Cortisol Ria Test Set	Ventrex Laboratories, Inc.	CGR	Class II	1979-12-06
K792221	Vance Philips Follower Catheter & Bougie	Vance Products, Inc.	KOE	Class II	1979-12-06
K792220	Vance Kidney Biopsy Brushes	Vance Products, Inc.	KOD	Class II	1979-12-06
K792219	Vance Malleable Tip Filiform	Vance Products, Inc.	KOE	Class II	1979-12-06
K792205	Seidel Intramedullary Plug	Howmedica Corp.	HWC	Class II	1979-12-06
K792197	Human Chorionic Gonadotropin (Ria)	Nuclear Medical Laboratories, Inc.	JHI	Class II	1979-12-06
K792179	Ao Flexible Fiber Optic S/colonoscope	American Optical Corp.	FDF	Class II	1979-12-06
K792150	Model 808 Adapter	Malibu Laboratories	GEI	Class II	1979-12-06
K792147	Arm Shield for Anesthesia	Medical Innovations, Inc.	BTX	Class I	1979-12-06
K792094	Browne Model Ua-6	Browne Corp.	FAP	Class II	1979-12-06
K792093	Browne Model Gd-5	Browne Corp.	FAP	Class II	1979-12-06
K792092	Browne Model Ud-4E	Browne Corp.	FAP	Class II	1979-12-06
K792091	Browne Model Ud-4D	Browne Corp.	FAP	Class II	1979-12-06
K792090	Browne Model Ud-4	Browne Corp.	FAP	Class II	1979-12-06
K792054	Erika Negative Pressure Venous Bl Sets	Erika, Inc.	FJK	Class II	1979-12-06
K792053	Erika Negative Pressure Arterila Blood	Erika, Inc.	FJK	Class II	1979-12-06
K791860	Ferritin Ria Kit	Cis Radiopharmaceuticals, Inc.	DBF	Class II	1979-12-06
K791676	Peritoneal Dialysis Cycler Model Pdc1000	J.M. Sounds Electronics Co.	KPF	Class II	1979-12-06
K792387	Implantable Endocardial Tined Electrode	Telectronics, Inc.	DTB	Class III	1979-12-05
K792385	Devo Oxygen Concentrator, Model 955	The Devilbiss Co.	CAW	Class II	1979-12-05
K792379	Cardiac Pacing Electrode	Medi-Dyne Instruments, Inc.	DTB	Class III	1979-12-05
K792359	Medtronic Model 9407 Teletrace Transmitt	Medtronic, Inc.	DXH	Class II	1979-12-05
K792355	Aneroid Sphymomanometer	Abco Dealers, Inc.	DXQ	Class II	1979-12-05
K792351	Medtronic Mod. 3852 Steril-Ice Electrode	Medtronic, Inc.	GXY	Class II	1979-12-05
K792348	Stanicor, Omni-Stan,mod 333B,334a Gamma	Cordis US Corp.	DTX	Class II	1979-12-05
K792253	Ariculated Tension Device Synthes Ten	Synthes (USA) Products LLC	HWN	Class I	1979-12-05
K792240	Polycentric Total Knee Metal Tibial	Howmedica Corp.	HSX	Class II	1979-12-05
K792237	Hearing Aid, Unitron Model 905W	Unitron Industries, Inc.	ESD	Class I	1979-12-05
K792204	Howmedica Compression Staple System	Howmedica Corp.	JDR	Class II	1979-12-05
K792203	Curved Kuntscher Intramedullary Nail	Howmedica Corp.	HSB	Class II	1979-12-05
K792200	Tillman Hip Resurfacing Replacemt Pros.	Waldemar Link GmbH & Co. KG	KXA	Class II	1979-12-05
K792186	Howmedica Mix-Kit II	Howmedica Corp.	JDZ	Class I	1979-12-05
K792145	Automatic Retractor Holders	Automated Medical Products Corp.	GAD	Class I	1979-12-05
K792144	Disposa-Hood	Utah Medical Products, Inc	FOG	Class I	1979-12-05
K792141	Continuous Flush Device	Pharmaseal Div., Baxter Healthcare Corp.	KRA	Class II	1979-12-05
K792113	Conphar Manometer Connectors	Conphar, Inc.	DTL	Class II	1979-12-05
K791891	Acu-Med Red Miser Hemothorax Blood Coll.	Acumed Instruments Corp.	CAC	Class II	1979-12-05
K792390	Moisture Trap	Dhd Medical Products Div. Diemolding Corp.	BYH	Class I	1979-12-04