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 2037 of 3531

510(k) clearances, page 2037 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K951451	Peba Anchor (Multiple Sizes)	Orthopaedic Biosystems, Ltd.	MBI	Class II	1995-10-31
K951041	Blood Pressure Cuff 3	Pedia Pals, Inc.	DXQ	Class II	1995-10-31
K951040	Blood Pressure Cuff 2	Pedia Pals, Inc.	DXQ	Class II	1995-10-31
K951039	Blood Pressure Cuff 1	Pedia Pals, Inc.	DXQ	Class II	1995-10-31
K950760	Analyst, Model Dsp 300	Heart Sounds, Inc.	DQD	Class II	1995-10-31
K950003	Cardiomagic(r) Software Enhancements	Instromedix, Inc.	DXH	Class II	1995-10-31
K942838	Olympus Superview Laparoscope for Ob/gyn	OLYMPUS Corporation of the Americas	HET	Class II	1995-10-31
K936311	Mitek Mini Anchor	Mitek Surgical Products, Inc.	MNV	Class II	1995-10-31
K954752	Pediatric Europhylic Foley Catheter	Regulatory & Marketing Services, Inc.	EZL	Class II	1995-10-30
K954708	Silane Primer	Sybron Dental Specialties, Inc.	KLE	Class II	1995-10-30
K954702	Implantaloy	Metalor Dental USA Corp.	EJT	Class II	1995-10-30
K954701	American Dental Products Pit & Fissue Sealant Light Curing	American Dental Products, Inc.	EBC	Class II	1995-10-30
K954689	Connect	Sybron Dental Specialties, Inc.	EBI	Class II	1995-10-30
K954670	Pressore Monitor	Cleveland Medical Devices, Inc.	IKE	Class I	1995-10-30
K954647	Inclinometer	J-Tech, Inc.	KQX	Class I	1995-10-30
K954544	Laser Gas Mixture	Liquid Technology Corp.	GEX	Class II	1995-10-30
K954539	Lg Hex Prosthetics	Implant Center of the Palm Beaches	DZE	Class II	1995-10-30
K954530	The Silencer	Silent Knights Ventures, Inc.	LRK	Class II	1995-10-30
K954408	American Dental Products Light Activated Composite Resin Core Buildup Blue Pastee	American Dental Products, Inc.	EBF	Class II	1995-10-30
K954407	American Dental Products White Composite Resin Core Paste with Fluoride	American Dental Products, Inc.	EBF	Class II	1995-10-30
K954406	American Dental Products Composite Resin Core Paste with Fluoride	American Dental Products, Inc.	EBF	Class II	1995-10-30
K954405	American Dental Prodducts Light Activated Composite Resin Core Paste with Fluoride	American Dental Products, Inc.	EBF	Class II	1995-10-30
K954162	Ergoseat System	Ergo-Air, Inc.	MOC	Class II	1995-10-30
K954133	American Dental Products Wetting Agent & Desensitizer	American Dental Products, Inc.	KLE	Class II	1995-10-30
K954081	Patient Examination Gloves (Non-Chlorinated Powder Free, Non-Sterile)	Tan Chong Rubber Gloves Sdn Bhd	LYY	Class I	1995-10-30
K953791	Vlv Sa Ef Infusion Port	VLV Associates, Inc.	FPA	Class II	1995-10-30
K953635	Titanium Dyna-Lok Spinal System	Sofamor Danek USA,Inc.	MNH	Class II	1995-10-30
K953578	Protek Acetabular Roof Reinforcement Ring	Intermedics Orthopedics	JDI	Class II	1995-10-30
K953542	Coldgel	Prism Technologies, Inc.	IMD	Class I	1995-10-30
K953536	Slant/fin Hepa Clear	Amcor, Ltd.	FRF	Class II	1995-10-30
K953399	Needle or Cutter	Biophysic Medical, Inc.	KNW	Class II	1995-10-30
K953224	Cobas Fp Reagent Application for Free Valproic Acid	Roche Diagnostic Systems, Inc.	LEG	Class II	1995-10-30
K953081	Beamer Plus	Aspen Laboratories, Inc.	GEI	Class II	1995-10-30
K952957	The Tulip Insulated Graspers	The Tulip Mfg. Co.	GCJ	Class II	1995-10-30
K952956	The Tulip Company Branson Double-Ended Dissector	The Tulip Mfg. Co.	GCJ	Class II	1995-10-30
K952955	The Tulip Company Branson Straight Dissector	The Tulip Mfg. Co.	GCJ	Class II	1995-10-30
K952954	The Tulip Company Weil-Blakesley Forceps	The Tulip Mfg. Co.	GCJ	Class II	1995-10-30
K952936	The Tulip Company Branson Anterior Elevator	The Tulip Mfg. Co.	GCJ	Class II	1995-10-30
K952934	The Tulip Company Branson Recurved Dissector	The Tulip Mfg. Co.	GCJ	Class II	1995-10-30
K952900	The Tulip Company Branson Soft Tissue Retractor	The Tulip Mfg. Co.	GCJ	Class II	1995-10-30
K952899	The Tulip Insulated Scissors	The Tulip Mfg. Co.	GCJ	Class II	1995-10-30
K952624	Cryo Check Abnormal Reference Check I & II	Precision Biologicals, Inc.	GGC	Class II	1995-10-30
K952622	Cryo Check Normal Human Reference Plasma	Precision Biologicals, Inc.	GGN	Class II	1995-10-30
K952052	Scinitrex (Powdered Nitrile Examination Glovesd)	Wembley Rubber Products (M) Sdn Bhd	LZA	Class I	1995-10-30
K951921	Scinitrex (Green Powdered Nitrile Examination Gloves)	Wembley Rubber Products (M) Sdn Bhd	LZA	Class I	1995-10-30
K944587	Dermiview Hypoallergenic Clear Tape	Johnson & Johnson MEDICAL GmbH	KGX	Class I	1995-10-30
K942987	Nucleotome L Kit	Surgical Dynamics Ltd	GET	Class I	1995-10-30
K954715	Micro-Planer Handpiece	Trebay Medical Corp.	ERL	Class II	1995-10-27
K954669	Femostop, Femostop Pump	Radi Medical Systems AB	DXC	Class II	1995-10-27
K954565	Explor-X (Azteh) HF	Chicago X-Ray Systems, Inc.	EAP	Class II	1995-10-27