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 1709 of 3531

510(k) clearances, page 1709 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K993286	Pioneer Silicoat Sternal Cable	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	JDQ	Class II	1999-11-23
K993273	N Latex Ferritin	Siemens Healthcare Diagnostics Inc.	DBF	Class II	1999-11-23
K993213	K-Assay Iga	Kamiya Biomedical Company, LLC	CFF	Class II	1999-11-23
K993128	Healthbuddy with Device Connect [Glucose Meter]	Health Hero Network, Inc.	CGA	Class II	1999-11-23
K993119	Sterile Hydrogel	Dumex Medical Surgical Products, Ltd.	MGQ	Unclassified	1999-11-23
K992994	Turbo 7000 Shaver and Drill Console; Turbo 7000 Handpieces; Essential Shaver/burrs;	Gyrus Ent LLC	ERL	Class II	1999-11-23
K992925	Ax Workstation Dr-Viewer Software Option	Siemens Corp.	LLZ	Class II	1999-11-23
K992920	Ebi Spinelink System	Ebi, LLC	MNI	Class II	1999-11-23
K992890	Roche Cobas Integra Opiates 300/2000	Roche Diagnostics GmbH	DJG	Class II	1999-11-23
K992538	Amorphous Diamond Coated Screw	Nobel Biocare Uas, Inc.	DZE	Class II	1999-11-23
K992341	Cidex Opa Solution Test Strip	Serim Research Corp.	JOJ	Class II	1999-11-23
K992330	The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery	Biomedics	JEY	Class II	1999-11-23
K992235	Zyranox Zirconia Ceramic Femoral Heads	Corin USA	LZO	Class II	1999-11-23
K991906	Laparo CO2-Pneu Automatic Insufflator with 30L Flow Rate,and Video-Screen Display, High Flow Insufflation Tube with Heat	Richard Wolf Medical Instruments Corp.	HIF	Class II	1999-11-23
K991473	Sirscan	Intelligence Artificielle Applications	KZK	Class I	1999-11-23
K990512	Stockert Power Supply Unit for S3 Components	Stoeckert Instrumente	KRI	Class I	1999-11-23
K983198	Trendcare Calibrator Model Scu 7007	Diametrics Medical, Inc.	CCC	Class II	1999-11-23
K972383	Easy-Jet Device	A.Stein - Regulatory Affairs Consulting	KLZ	Class II	1999-11-23
K993666	Disetronic Pen P100	Disetronic Medical Systems	FMF	Class II	1999-11-22
K993540	Endospine Operating Tube and Telescope Bridge	Karl Storz Endoscopy-America, Inc.	HRX	Class II	1999-11-22
K993501	3D1 Micropositioning Headstage	Scientific Tools, Inc.	HAW	Class II	1999-11-22
K993046	Fibra Sonics Ultrasonic Lithotriptor Lithosonic, Model Ls-2000	Fibra Sonics, Inc.	FEO	Class II	1999-11-22
K992887	Stak-Chex Plus Retics	Streck Laboratories, Inc.	GLQ	Class II	1999-11-22
K992852	Suture Clinch	Applied Medical Resources Corp	GCJ	Class II	1999-11-22
K992829	Cascade Liquid Coagulation Control Levels 1, 2, and 3	Medical Analysis Systems, Inc.	GGN	Class II	1999-11-22
K992242	Pillar Nasal, Dorsal Columella and Nasal Dorsum Implants	Pillar Surgical, Inc.	FZE	Class II	1999-11-22
K992240	Pillar Malar Implant	Pillar Surgical, Inc.	LZK	Class II	1999-11-22
K992239	Pillar Chin Implant	Pillar Surgical, Inc.	FWP	Class II	1999-11-22
K992125	Xr 46 Dxa (Central) Bone Densitometer, Model Xr 46	Norland Medical Systems, Inc.	KGI	Class II	1999-11-22
K993823	Med-4000	Micro Current Technology, Inc.	GZJ	Class II	1999-11-19
K993649	Ebi Xfix Dfs Wristfix System	Ebi, LLC	KTT	Class II	1999-11-19
K993603	Wichita Fusion Nail Fully Threaded Self-Tapping Screw	Howmedica Osteonics Corp	HSB	Class II	1999-11-19
K993555	Masimo Set/quartz 2500 Pulse Oximeter and Accessories	Masimo Corporation	DQA	Class II	1999-11-19
K993479	Omni Grace Latex Examination Glove, Powdered, with Protein Claim (100 Micrograms or Less)	Omnigrace (Thailand), Ltd.	LYY	Class I	1999-11-19
K993419	Omnigrace Latex Examination Glove, Powder-Free; Polymer Coated with Protein Claim (50 Micrograms or Less)	Omnigrace, Ltd.	LYY	Class I	1999-11-19
K993352	Crossfire System 12 Acetabular Inserts	Howmedica Osteonics Corp	LPH	Class II	1999-11-19
K993348	Nil, Nitrile Examination Glove - Powder Free	Sri Anusham Rubber Industries Pvt., Ltd.	LZA	Class I	1999-11-19
K993347	Nil, Nitrile Examination Glove - Powdered	Sri Anusham Rubber Industries Pvt., Ltd.	LZA	Class I	1999-11-19
K993311	Comfit Powder Free Nitrile Examination Glove, Sterile	WRP Asia Pacific Sdn Bhd	LZA	Class I	1999-11-19
K993183	Powder Free Gloves (Polymer Coated)	Pan-Century Rubber Products Sdn. Bhd.	LYY	Class I	1999-11-19
K993082	Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular Component	Exactech, Inc.	LPH	Class II	1999-11-19
K993061	Stryker Leibinger Resorbable Fixation System	Stryker Corp.	MAI	Class II	1999-11-19
K993049	Disposable PVC Powdered Synthetic Examination Gloves	Shanghai Antares Industries, Inc.	LYZ	Class I	1999-11-19
K992964	Ibc Vent Valve, Model 1400	International Biophysics Corp.	MNJ	Class II	1999-11-19
K992952	Lorenz Distraction System	Biomet Microfixation	MQN	Class II	1999-11-19
K992919	Oxy-Glide Root Canal Cleanser & Lub.	Super Glide, Inc.	KJJ	Unclassified	1999-11-19
K992885	Versalok Low Back Fixation System	Osteotech Inc	KWP	Class II	1999-11-19
K992881	Hi Bond Non-Precious Ceramic Alloy	Matech, Inc.	EJH	Class II	1999-11-19
K992848	Alarmview System	Data Critical Corp.	MSX	Class II	1999-11-19
K992832	Sulzer Vascutek Eptfe Vascular Prosthesis	Sulzermedica	DSY	Class II	1999-11-19