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 1280 of 3531

510(k) clearances, page 1280 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K060162	Acl Elite; Acl Elite Pro	Instrumentation Laboratory Co.	JPA	Class II	2006-02-21
K053635	Modification to Rightest Blood Glucose Monitoring System	Bionime Corporation	NBW	Class II	2006-02-21
K053374	Ossaplast Dental (Particle Size of 500 to 1000 Um to 2000 Um)	Ossacur AG	LYC	Class II	2006-02-21
K053367	Male Natural Rubber Latex Condom	Innolatex Sdn. Bhd	HIS	Class II	2006-02-21
K052823	Implantium Abutments	Dentium Co., Ltd.	NHA	Class II	2006-02-21
K052705	Dart-12	Direx Systems Corp.	IYE	Class II	2006-02-21
K051244	Genzyme Osom Influenza a & B Test	Genzyme Corporation	PSZ	Class II	2006-02-21
K060293	Temporary Crown and Bridge Material	Dentsply International, Inc.	EBG	Class II	2006-02-17
K060221	The Phillips, Model Mp20,mp30,mp40,mp50,mp60,mp70,mp80,and Mp90 Intellivue Patient Monitors	Philips Medizin Systeme Boeblingen GmbH	MHX	Class II	2006-02-17
K060174	Spectrum Five Lumen Central Venous Catheter Set, Model C-Uqlm10.0-Abrm	Cook Inc.	FOZ	Class II	2006-02-17
K060091	Alliance Medical Corporation Reprocessed Compression Sleeves	Alliance Medical Corp.	JOW	Class II	2006-02-17
K060019	Arton One-Step Hcg Urinary Pregnancy Test (Strip), (Cassette), (Midstream)	Artron Laboratories Inc.	LCX	Class II	2006-02-17
K053581	Nuvasive Smartplate Gradient Plus System	NuVasive Inc	KWQ	Class II	2006-02-17
K053558	Ceph, Model 4900	Schick Technologies, Inc.	MUH	Class II	2006-02-17
K053397	K-Y Brand Sensual Mist	Mcneil-Ppc, Inc.	NUC	Class II	2006-02-17
K053318	Rx Epidural Needle	Epimed International, Inc.	BSP	Class II	2006-02-17
K053253	Hemocue Albumin 201 Analyzing System	HemoCue AB	KQO	Class I	2006-02-17
K053148	Cxr16	FUJIFILM Healthcare Americas Corporation	JAK	Class II	2006-02-17
K052828	Disposable Transpac III Integrated Transducer (It)	Abbott Medical	DRS	Class II	2006-02-17
K052676	Kd-322 Semi Automatic Electronic Blood Pressure Monitor	Kodon(Tianjin)Electronic&Electrical Apparatus Co.	DXN	Class II	2006-02-17
K052659	Spiderx Embolic Protection Device	Medtronic, Inc.	NTE	Class II	2006-02-17
K052347	Titan Steerable (Ptca) Guidewire	Lake Region Mfg., Inc.	DQX	Class II	2006-02-17
K052089	Xr-Series Bi-Metric Femoral Components	Biomet Manufacturing Corp	LPH	Class II	2006-02-17
K052057	Lifepak 500 Automated External Defibrillator	Physio Control, Inc.	MKJ	Class III	2006-02-17
K051931	Axcel	Tri Dental Innovators	EBF	Class II	2006-02-17
K051636	Camlog Dental Implant Abutments, Healing Caps, and Accessories	Altatec GmbH	NHA	Class II	2006-02-17
K051525	Arx Spinal System	Amedica Corp.	MQP	Class II	2006-02-17
K051175	Civ-Ob Obstrical Monitoring Software Application	Civent Communications, Ltd.	HGM	Class II	2006-02-17
K050086	Brennen Medical Silver Glucan Wound Dressing	Brennen Medical, Inc.	FRO	Unclassified	2006-02-17
K060183	Erbe Apc Integrated Filter Probes; Erbe Apc Integrated Filter Probe Adapter	Erbe USA Inc	GEI	Class II	2006-02-16
K060170	Erbe Biclamp Open and Laparoscopic Instruments	Erbe USA Inc	GEI	Class II	2006-02-16
K060133	Ischemia Albumin Cobalt Binding Test (Acb) Assay Verification Set	Inverness Medical Innovations, Inc.	JJX	Class I	2006-02-16
K060108	Cobas Integra Chloride Elctrode Gen.2	Roche Diagnostics GmbH	CGZ	Class II	2006-02-16
K053512	Homechoice/homechoice Pro Personal Cycler Peritoneal Dialysis System, Models 5C4471 and 5C8310	Baxter Healthcare Corporation	FKX	Class II	2006-02-16
K053376	Chung Cheng Far Infrared Ray Healthful Lamp (or Medical Fir Radiator), Model Ch-8810	Chung Cheng Electric Heating Co., Ltd.	ILY	Class II	2006-02-16
K053293	Encompass 1017 and 1217 Extended Press-Fit Hip Stems	Ortho Development Corp.	LPH	Class II	2006-02-16
K053183	Jive X Software	Visus Technology Transfer GmbH	LLZ	Class II	2006-02-16
K053139	Fotona Qx Nd:yag/ktp Laser System	Fotona D.D.	GEX	Class II	2006-02-16
K053108	Dimension Csae Cyclosporine Extended Range Calibrator, Model Dc108	Siemens Healthcare Diagnostics Inc.	DLJ	Class II	2006-02-16
K052168	Medline Silvertouch 100% Silicone Foley Catheter, Model Medline Industries, Inc.	MEDLINE INDUSTRIES, LP - Northfield	EZL	Class II	2006-02-16
K051489	Euroimmun Anca Ifa Granulocyte Biochip Moscaic Igg Antibody in Human Serum	Euroimmun US Inc.	MOB	Class II	2006-02-16
K050956	Tbr Idea Conic/conic	Sudimplant SA	DZE	Class II	2006-02-16
K060131	Oss-Bodies Proximal Tibial Sleeve	Biomet Manufacturing Corp	KRO	Class II	2006-02-15
K053575	Hygia Health Services Reprocessed Kendall Scd Express Sleeves/foot Cuffs	Hygia Health Services, Inc.	JOW	Class II	2006-02-15
K053566	Modification to: Diazyme Potassium Enzymatic Assay, Model Dz113a	Diazyme Laboratories, Inc.	MZV	Class II	2006-02-15
K053391	X-Tra Fil	Voco GmbH	EBF	Class II	2006-02-15
K053389	Aesculap Sterilcontainer System	Aesculap Inc	FRG	Class II	2006-02-15
K053352	Comfortlite Nasal Mask	Respironics, Inc.	BZD	Class II	2006-02-15
K053329	Korlex-Gr Gingival Retraction Paste	Biotech One, Inc.	MVL	Unclassified	2006-02-15
K053212	Raven Propact	Raven Biological Laboratories, Inc.	MRB	Class II	2006-02-15