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 1343 of 3531

510(k) clearances, page 1343 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K050118	Ebi Trochanteric Nail System	Ebi, LLC	HSB	Class II	2005-02-16
K050104	Apex Medical Minineb & Miniplus	Apex Medical, Inc.	CAF	Class II	2005-02-16
K050103	Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System	Abbott Medical	FGE	Class II	2005-02-16
K043498	Twin Power Turbine High Speed Air Turbine Dental Handpiece	J. Morita USA, Inc.	EFB	Class I	2005-02-16
K043496	Spaceline Emcia, Model Cu580	J. Morita USA, Inc.	EIA	Class I	2005-02-16
K043431	Gamma3 Nail System	Howmedica Osteonics Corp	HSB	Class II	2005-02-16
K043421	Opteform, Osteofil, Rti Allograft Paste Ic, Rti Allograft Strip Ic	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	MQV	Class II	2005-02-16
K043387	Vascon Polaris Guiding Catheter	Vascon, LLC	DQY	Class II	2005-02-16
K043374	Duracon Conversion and X-Small Symmetric Patella with Peri-Apatite Coating	Howmedica Osteonics Corp	MBH	Class II	2005-02-16
K043308	Modification to: Healos Bone Graft Material	DePuy Spine, Inc.	MQV	Class II	2005-02-16
K043248	Tightrope Syndesmosis Repair Kit, Titanium, Model Ar-8920Ds; Stainless Steel. Model Ar-8921Ds	Arthrex GmbH	HTN	Class II	2005-02-16
K043199	Surgical Face Mask	Hong YA Non-Woven Products Co., Ltd.	FXX	Class II	2005-02-16
K042360	Varian Nasopharynx Applicator	Varian Medical Systems, Inc.	JAQ	Class II	2005-02-16
K033696	Personal Injector	Union Medico ApS	KZH	Class II	2005-02-16
K050240	Modification to Acuson Cv70 Cardiovascular System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2005-02-15
K050218	Wavelight Sinon	Wavelight Laser Technologie AG	GEX	Class II	2005-02-15
K050132	Neuro II-S	Innovative Magnetic Resonance Imaging Systems, Inc.	LNH	Class II	2005-02-15
K050077	Spotchem II Calcium, Magnesium, and Blood Urea Nitrogen Tests	Arkray, Inc.	CIC	Class II	2005-02-15
K043476	Stratus Cs Acute Care Nt-Probnp Testpak, Pbnp Calpak Calibrator, Pbnp Dilpak Diluent	Siemens Healthcare Diagnostics Inc.	NBC	Class II	2005-02-15
K043438	Large Bore Splittable Introducer Kit	Merit Medical Systems, Inc.	DYB	Class II	2005-02-15
K043370	Planet 50 Monitoring System	Larsen & Toubro Limited	MWI	Class II	2005-02-15
K043268	Sodium Test Kit and Eletrolyte Cal 1 and 2	Randox Laboratories, Limited	CEI	Class II	2005-02-15
K043266	Randox Urine Controls	Randox Laboratories, Limited	JJW	Class I	2005-02-15
K043147	Achieva Family	Philips North America LLC	LNH	Class II	2005-02-15
K043139	Uscom 1A	Uscom, Ltd.	IYN	Class II	2005-02-15
K042884	Dakocytomation Er/pr Pharmdx Kit	Agilent Technologies, Inc.	MXZ	Class II	2005-02-15
K042735	N Antisera to Human Immunoglobulins (Igg, Iga and Igm)	Siemens Healthcare Diagnostics Inc.	CFN	Class II	2005-02-15
K041839	8None	Medical Solutions, Inc.	LGZ	Class II	2005-02-15
K040958	Prestige Models 24I and 400 and Mgc Model 240	Tokyo Boeki Medical System, Ltd.	JJE	Class I	2005-02-15
K050203	Allux	Wieland Dental + Technik GmbH & Co. KG	EIH	Class II	2005-02-14
K043589	Microscan Dried Gram-Positive Mic/combo Panels - Ertapenem	Dade Microscan, Inc.	JWY	Class II	2005-02-14
K043222	Viscucam C Digital Camera	Carl Zeiss Meditec Inc	HKI	Class II	2005-02-14
K042730	Calforma Calcium Sulfate Bone Graft Barrier, Model 0.5G/1.0g	Lifecorebiomedical	LYC	Class II	2005-02-14
K042659	Medisiss Reprocessed Non-Electric Gi Biopsy Forceps	Medisiss	NON	Class I	2005-02-14
K033862	Bioteq Pigtail Drainage Catheter Set (One Step Type) with or without Safety String Lock	Bioteque Corp.	FGE	Class II	2005-02-14
K050264	Stealth Products Seating System	Stealth Products	ITI	Class II	2005-02-11
K050226	Asian Intramedullary Hip Screw Nails	Smith & Nephew, Inc.	HWC	Class II	2005-02-11
K050180	Expa-Syl	Produits Dentaires Pierre Rolland	MVL	Unclassified	2005-02-11
K050141	The Philips Mp20, Mp30, Mp40, Mp50, Mp60, Mp70 and Mp90 Intellivue Patient Monitors	Philips Medizin Systeme Boeblingen GmbH	MHX	Class II	2005-02-11
K050109	Trillium Biopump Plus, Model Bpx80t	Medtronic Perfusion Systems	KFM	Class II	2005-02-11
K050107	Harvard 2 Syringe Pump, Model 2001-001	Harvard Clinical Technology	FRN	Class II	2005-02-11
K050073	Modification to Amphirion Deep 0.014 Otw Pta Balloon Catheter	Invatec Innovative Technologies, S.r.l.	DQY	Class II	2005-02-11
K050033	Lucion	Mevisys Co., Ltd.	LLZ	Class II	2005-02-11
K050011	Wu's Powered Wheelchair, Mambo F 120	Wu's Tech Co., Ltd.	ITI	Class II	2005-02-11
K050010	Wu's Powered Wheelchair, Mambo 36X	Wu's Tech Co., Ltd.	ITI	Class II	2005-02-11
K043523	Interv Brand Snarelok Bone Marrow Biopsy Needle	Medical Device Technologies, Inc.	KNW	Class II	2005-02-11
K043506	Acupuncture Needles	Marknew Products	MQX	Class II	2005-02-11
K043463	Envitec Reusable Multi-Site Y Spo2 Sensors	Envitec-Wismar GmbH	DQA	Class II	2005-02-11
K043435	Quickie Interchange Fwd W/lift Power Wheelchair	Sunrise Medical, Inc.	ITI	Class II	2005-02-11
K043407	Inf 4160, Model D-Fj27f	FUJI Dynamics Limited	LIH	Class II	2005-02-11