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 2026-11-02, 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 991 of 3531

510(k) clearances, page 991 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K102854	Pc ECG	Edan Instruments, Inc.	DPS	Class II	2010-12-03
K102818	Micrus One 2 One Guidewire, Micrus One 2 One Soft Guidewire	Micrus Endovascular Corporation	DQX	Class II	2010-12-03
K102812	Gamma-Bsm; Beta-Bsm; Equivabone	Etex Corp.	LYC	Class II	2010-12-03
K102688	Merete Locking Bone Plate System II	Merete GmbH	KTT	Class II	2010-12-03
K102654	Vertex Rapid Simplified	Vertex-Dental B.V.	EBI	Class II	2010-12-03
K102607	Fidistm Connective 10, Fidistm Analyzer, Caris	Biomedical Diagnostics (Bmd) SA	LLL	Class II	2010-12-03
K102459	Nexstat (Tm) Topical Hemostat Powder; Nexfoam (R) Topical Sponge	Hemostasis, LLC	QSY	Unclassified	2010-12-03
K102382	Sfi-Bar Implant Adapter Straumann, Sfi-Bar Implant Adapter for Neoss Implant	Cendres & Metaux SA	NHA	Class II	2010-12-03
K102313	Patriot Transcontinental M Spacers	Globus Medical, Inc.	MAX	Class II	2010-12-03
K102305	Hass Zirtooth Model Zortooth H. Zirtooth T. Zirtoothc, Zirtooth P	Hass Corp.	EIH	Class II	2010-12-03
K102252	Dmp Pit & Fissure Sealant	Dmp, Ltd.	EBC	Class II	2010-12-03
K102244	Reliance Endoscope Processing System	STERIS Corporation	NZA	Class II	2010-12-03
K102209	Encode Patient Specific Abutment	ZimVie US Corp LLC	NHA	Class II	2010-12-03
K101907	Haemonetics Cell Saver Elite Autotransfusion System	Haemonetics Corporation	CAC	Class II	2010-12-03
K101835	Medpor Fixation System-Cranial, Models 80080, 80079	Porex Surgical, Inc.	HBW	Class II	2010-12-03
K101730	Longevity It Highly Crosslinked Polyethylene Constrained Liners	Zimmer GmbH	KWZ	Class II	2010-12-03
K101690	Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper Cable	Sentec AG	LKD	Class II	2010-12-03
K101267	Premio 10 Moxa	Sedatelec	ILY	Class II	2010-12-03
K101229	Longevity It Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular System and Trilogy Integrated Taper	Zimmer GmbH	LPH	Class II	2010-12-03
K101224	Saphenamedical Anti-Embolism Stockings	Griffiths and Nielsen, Ltd.	DWL	Class II	2010-12-03
K100837	Pacentric Connect, Traveler and Web	Fimreite Software AS	LLZ	Class II	2010-12-03
K100785	Bonart Model Art-Im1 Implantor System & Accessories	Bonart Co. Ltd.	EBW	Class I	2010-12-03
K100761	Biopro Polar Head	Biopro, Inc.	KWY	Class II	2010-12-03
K100731	Bosworth Air Polisher	Harry J. Bosworth Co.	EFB	Class I	2010-12-03
K100516	Anyplus Peek Cages	GS Medical Co., Ltd.	OVD	Class II	2010-12-03
K100445	Klassic Hd Hip System	Total Joint Orthopedics, Inc.	LPH	Class II	2010-12-03
K100126	Stellate Gridview	Excel-Tech Ltd. (Xltek)	OLX	Class II	2010-12-03
K100040	Bioharness	Zephyr Technology Corporation	MHX	Class II	2010-12-03
K093565	Pleuraflow Catheter System	Clear Catheter Systems	OTK	Class II	2010-12-03
K092587	Bioplex 2200 Rubella & Cmv Igm Kit on the Bioplex 2200 Multi Analyte Detection System	Bio-Rad Laboratories Inc.	LFX	Class II	2010-12-03
K103284	Laminoplasy Plating System	Aesculap Inc	NQW	Class II	2010-12-02
K102842	Adhesive Electrodes	Reno Medical, Ltd.	GXY	Class II	2010-12-02
K102830	Electrocardiograph	Edan Instruments, Inc.	DPS	Class II	2010-12-02
K102768	Secrmark Biopsy Site Marking System	Hologic, Inc.	NEU	Class II	2010-12-02
K102579	Hyperq Ad-100 System	Biological Signal Processing, Ltd.	MWI	Class II	2010-12-02
K102525	Breathe Technologies Ventilator and Accessories (Bt-V2s)	Breathe Technologies, Inc.	ONZ	Class II	2010-12-02
K102404	Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea Therapy (Provent 50)	Ventus Medical, Inc.	OHP	Class II	2010-12-02
K102399	Consensus Taperset Hip System	Consensus Orthopedics, Inc.	LPH	Class II	2010-12-02
K102352	Evolve Eps Ortholoc	Wrightmedicaltechnologyinc	HRS	Class II	2010-12-02
K102179	Enview (Tm)	Medtronic, Inc.	OCV	Class II	2010-12-02
K101577	Modification To:fingertip Pulse Oximeter, Model Md300c Series	Beijing Choice Electronic Technololgy Co., Ltd.	DQA	Class II	2010-12-02
K101126	Pontis Sutures and Suture Anchors with Optional Crimps	Core Essence Orthopaedics, LLC	MBI	Class II	2010-12-02
K103313	Heparin Assay Controls	Medtronic, Inc.	GGN	Class II	2010-12-01
K103214	M3810a Philips Telemonitoring System with Edevice Bridged130	Lifeline Systems, Inc.	DRG	Class II	2010-12-01
K102639	Sl3	Discus Dental LLC	GEX	Class II	2010-12-01
K102599	Tomophase Octis	Tomophase Corporation	NQQ	Class II	2010-12-01
K102587	Llx240ab01	Samsung Mobile Display Co., Ltd.	MQB	Class II	2010-12-01
K102543	Bravo Ph Monitoring System and Accessories	Given Imaging Ltd.	FFT	Class I	2010-12-01
K102536	Vitala Continence Control Device	ConvaTec Limited	EZQ	Class I	2010-12-01
K102514	Nuvasive Spherx II -Mas Deformity Spinal System	NuVasive Inc	NKB	Class II	2010-12-01