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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 693 of 3530

510(k) clearances, page 693 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K151733	Xenco Medical Pedicle Screw System	Xenco Medical LLC	NKB	Class II	2015-09-04
K151538	NuVasive PEEK Corpectomy Railed System	Nu Vasive, Incorporated	MQP	Class II	2015-09-04
K151521	Phoenix Thera-Lase System	Phoenix Thera-Lase Systems, LLC	ILY	Class II	2015-09-04
K151442	Total Compression Plating (Tcp) System	Wrightmedicaltechnologyinc	HRS	Class II	2015-09-04
K151270	CrossTIE Intraosseous Fixation System	Crossroads Extremity Systems LLC	HWC	Class II	2015-09-04
K151249	Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2 Gallon, Pureway Sharps Collector 3 Gallon	Pureway Compliance, Inc.	MMK	Class II	2015-09-04
K151248	Piezosurgery White	Mectron S.p.A.	DZI	Class II	2015-09-04
K151160	Arcus Staple System	Medartis AG	JDR	Class II	2015-09-04
K151040	Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer	Biometrix Ltd.	DRS	Class II	2015-09-04
K150768	JuggerKnot Soft Anchors	Biomet Manufacturing Corp	MBI	Class II	2015-09-04
K150442	Volcano Visions PV .018 Digital IVUS Catheter	Volcano Corporation	OBJ	Class II	2015-09-04
K150064	Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)	Orthogem Limited	MQV	Class II	2015-09-04
K143653	Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)	Luminex Corporation	OCC	Class II	2015-09-04
K143597	Navigated XIA 4.5 Polyaxial Screwdriver	Stryker Corporate	OLO	Class II	2015-09-04
K152396	S12 Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	IYN	Class II	2015-09-03
K152250	SpeqRT	Signostics Limited	IYN	Class II	2015-09-03
K152230	Ebony PTA .014 RX Pheripheral Dilatation Catheter	Natec Medical Ltd	LIT	Class II	2015-09-03
K152220	Mh01	Quanta System Inc.	GEX	Class II	2015-09-03
K152170	Exactech Optetrak Logic Enhanced Assembly	Exactech, Inc.	JWH	Class II	2015-09-03
K151902	REDAPT¿ Revision Femoral System	Smith & Nephew, Inc.	LZO	Class II	2015-09-03
K151885	SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System	DePuy Synthes	NKG	Class II	2015-09-03
K151705	Lotus Posterior Cervical/Thoracic Spinal System	Spinal Elements, Inc	NKG	Class II	2015-09-03
K151666	Leksell GammaPlan	Elekta Instrument AB	MUJ	Class II	2015-09-03
K151440	Klassic HD Hip System	Total Joint Orthopedics, Inc.	LPH	Class II	2015-09-03
K151167	NuVasive PEEK Corpectomy System	Nu Vasive, Incorporated	MQP	Class II	2015-09-03
K150852	Sic 8000	Cosmo Technologies Ltd.	PLL	Class II	2015-09-03
K150812	Genesys Spine Apache Cervical Interbody Fusion System	Genesys Spine	ODP	Class II	2015-09-03
K150265	Model 206 Electrometer/Dosimeter	Cnmc Company Incorporated	IYE	Class II	2015-09-03
K143631	Benefix Interspinous Fixation System	CG MedTech Co., Ltd.	PEK	Class II	2015-09-03
K142982	OPUS 5100 Diagnostic Doppler Ultrasound System	Chang Gung Medical Technology Co., Ltd.	IYN	Class II	2015-09-03
K141960	Exactech® Novation® Crown Cup®	Exactech, Inc.	LPH	Class II	2015-09-03
K140310	Peristeen Anal Irrigation System	MEDLINE INDUSTRIES, LP - Northfield	KNT	Class II	2015-09-03
K152208	The Belmont Hyperthermia Pump	Belmont Medical Technologies	LGZ	Class II	2015-09-02
K152148	Fortress Pedicular Fixation System	Spineology, Inc.	NKB	Class II	2015-09-02
K152143	TRUCLEAR Operative Hysteroscope 5C and Sheath 5C	Smith & Nephew, Inc.	HIH	Class II	2015-09-02
K151869	Microlife Upper Arm Automatic Digital Blood Pressure Monitor	Microlife Intellectual Property GmbH, Switzerland	DXN	Class II	2015-09-02
K151860	Infinity CentralStation Wide	Draeger Medical Systems, Inc.	MHX	Class II	2015-09-02
K151783	COMPACT INTUITIV Multiple-Use Pack	Advanced Medical Optics, Inc.	HQC	Class II	2015-09-02
K151766	BD Single Use, Hypodermic Syringe	Becton Dickinson & Co	FMF	Class II	2015-09-02
K150352	V Series Monitoring System (including V12 and V21 Monitors)	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	MHX	Class II	2015-09-02
K150124	Cardinal Health NPWT PRO HC	Cardinalhealth	OMP	Class II	2015-09-02
K150082	Panorama Patient Monitoring Network	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	MHX	Class II	2015-09-02
K143661	DirectInject	Stryker Corp.	GXP	Class II	2015-09-02
K143586	FACT Medical Imaging Sysytem	Dexin Medical Imaging Technology Co., Ltd.	LLZ	Class II	2015-09-02
K143267	TempTraq TT-100	Blue Spark Technologies, Inc.	FLL	Class II	2015-09-02
K142592	CleanSmart Wound Cleanser	Simple Science, LLC	FRO	Unclassified	2015-09-02
K140939	Hamilton-T1,hamilton-C1	Hamilton Medical AG	CBK	Class II	2015-09-02
K151957	BOX DICOM Viewer	Box, Inc.	LLZ	Class II	2015-09-01
K151575	Dynarex Eye Cups	Dynarex Corp.	LXQ	Unclassified	2015-09-01
K151473	NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module	Focus Medical, LLC.	GEX	Class II	2015-09-01