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 2020 of 3531

510(k) clearances, page 2020 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K955506	Hycure	The Hymed Group Corp.	KGN	Unclassified	1996-01-17
K955502	The Tulip Mono Polar Rotatable Metz Scissors	The Tulip Mfg. Co.	GEI	Class II	1996-01-17
K955501	The Tulip Mono Polar Rotatable Alligator Forcep	The Tulip Mfg. Co.	GEI	Class II	1996-01-17
K955084	Aspach 65,000 (Modification)	The Anspach Effort, Inc.	HSZ	Class I	1996-01-17
K955006	Eclipse 2100	Cardiogenes	GEX	Class II	1996-01-17
K954940	Mdt Sterigrip Disposable, Soft Cover, Light Handle	Mdt Biologic Co.	FTA	Class II	1996-01-17
K954922	Rexton's Horizion Family of Multiple Situation, Single Channel Programmbale Instruments	Rexton, Inc.	ESD	Class I	1996-01-17
K954834	Ceralas G Frequency Doubled Nd;yag Laser System	Ceram Optec, Inc.	GEX	Class II	1996-01-17
K954811	Depuy Advantage Hip Femoral Prosthesis with Porocoat	Depuy, Inc.	LPH	Class II	1996-01-17
K954797	Karl Storz Rhino-Laryngo-Broncho Fiberscope, Fiberscope for Bronchoscopy	Karl Storz Endoscopy-America, Inc.	EOQ	Class II	1996-01-17
K954698	Trilogy Acetabular Component 7Mm Offset	Zimmer GmbH	LPH	Class II	1996-01-17
K954157	Dg Portable System	Medelec, Ltd.	OLT	Class II	1996-01-17
K954148	Suture Washer	Acu Med, Inc.	HTN	Class II	1996-01-17
K954022	Aloka Omniview Diagnostic Ultrasound System	Aloka Co., Ltd.	IYN	Class II	1996-01-17
K953453	Symbiosis Monopolar Electrosurgical Roller Electrodes	Boston Scientific Corporation	FAS	Class II	1996-01-17
K953268	Dual Taper Wedge Pressed Fit Femoral Component	Globus Medical, Inc.	LWJ	Class II	1996-01-17
K952970	Howmedica Femoral & Proximal Tibial Modular Replacement Sytesm	Howmedica Corp.	JDI	Class II	1996-01-17
K952544	Colorslider Rubella	Seradyn, Inc.	LQN	Class II	1996-01-17
K952329	Life-Air 1000 Hypothermic Therapy System	Progressive Dynamics, Inc.	DWJ	Class II	1996-01-17
K952314	Exl-12Sp & 12Dp Linac	Mitsubishi Intl. Corp.	IYE	Class II	1996-01-17
K951517	Osteonics Secur-Fit Ha Plus Hip Stem Series	Osteonics Corp.	MEH	Class II	1996-01-17
K943314	Adhesive Bandages with OTC Drug	Johnson & Johnson Consumer Products, Inc.	KGX	Class I	1996-01-17
K924709	Satcare Oxygen Controller/monitor W/ Pulse Oximete	Air-Shields, Inc.	KLK	Class II	1996-01-17
K954790	Profile Nickel Titanium Rotary Instruments	Tulsa Dental Products LLC	DZA	Class I	1996-01-16
K954722	Micro-Dispenser 7000 & Microdispenser 8000	Nouvag AG	EFB	Class I	1996-01-16
K954645	Titanium Gdlh Posterior Spinal System	Sofamor Danek USA,Inc.	KWP	Class II	1996-01-16
K954501	Biotrend Oxygen Saturation & Hematocrit System	Medtronic Bio-Medicus, Inc.	DTY	Class II	1996-01-16
K953265	Scimed Angiographic Kits	Scimed Life Systems, Inc.	DQY	Class II	1996-01-16
K952347	A-1050 EEG Monitor	Aspect Medical Systems, Inc.	OLT	Class II	1996-01-16
K952065	Paceart Cardiovoice	Paceart, Inc.	DXH	Class II	1996-01-16
K951096	Lifesigns Receiving Cener 2000 Transtelephonic Receiver	Instromedix, Inc.	DXH	Class II	1996-01-16
K951094	Point-of-Care Arterial Blood Gas Monitoring System	Optical Sensors, Inc.	CCC	Class II	1996-01-16
K955572	Sunglasses with Impact Resistant Lenses	Diamond Mark International Co., Ltd.	HQY	Class I	1996-01-11
K955048	Kis Med Thread Implant & Prosthesis System	Implant Center of the Palm Beaches	DZE	Class II	1996-01-11
K955046	Soft Venous Reservoir	Gish Biomedical, Inc.	DTN	Class II	1996-01-11
K954865	Restore Ha Dental Implant System	Lifecore Biomedical LLC	DZE	Class II	1996-01-11
K954819	Restore Tps Dental Implant System Sustain Tps Dental Implant System	Lifecore Biomedical LLC	DZE	Class II	1996-01-11
K954766	Pressure Guard Alternating Pressure Mattress	Span-America Medical Systems, Inc.	FNM	Class II	1996-01-11
K954746	Phaco Tip	U.S. Iol, Inc.	HQC	Class II	1996-01-11
K954716	Deroyal Industries Infant Heel Warmer	Debusk Knitting Mills, Div. Deroyal Industries	MPO	Class I	1996-01-11
K954667	Monotube Tube-to-Tube Clamp	Howmedica Corp.	JEC	Class II	1996-01-11
K954659	Moonshades Sunglasses	Blublocker LLC	HQY	Class I	1996-01-11
K954431	Percutaneous Intra-Aortic Balloon Catheters	Boston Scientific Corporation	DSP	Class II	1996-01-11
K954093	Lumax (Modification)	Greatbatch Medical	FEN	Class II	1996-01-11
K953360	R-Med Abdominal Wall Elevator	R-Med, Inc.	HET	Class II	1996-01-11
K953204	Pediatric Quik-Combo	Physio Control, Inc.	MKJ	Class III	1996-01-11
K953008	Infant Feeding Tube	Marquette Medical, Inc.	FPD	Class II	1996-01-11
K952659	Tronomate Patient Cable & Leadwire System	Tronomed, Inc.	DSA	Class II	1996-01-11
K952572	Dialysis Administration Kits	B.Braun Medical, Inc.	KOC	Class II	1996-01-11
K951311	Gambro Hc 14R Hemoconcentrator	Cobe Renal Care, Inc.	KDI	Class II	1996-01-11