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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 599 of 3529

510(k) clearances, page 599 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K163303	OsteoMed ExtremiFix Mid and Large Screw System	Osteomed	HWC	Class II	2017-04-04
K163221	Mazor X	Mazor Robotics Ltd	OLO	Class II	2017-04-04
K162782	iHelmet Hair Growth System	Slinph Technologies Co., Ltd	OAP	Class II	2017-04-04
K162544	OsteoMed PINNACLE Driver	Osteomed	KMW	Class II	2017-04-04
K162206	Zavation IBF	Zavation	MAX	Class II	2017-04-04
K170075	AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)	Airxpanders, Inc.	PQN	Class II	2017-04-03
K163426	ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension	Asahi Intecc Co., Ltd.	DQX	Class II	2017-04-03
K162241	TITAN 3-D™ Wedge System	Paragon 28	PLF	Class II	2017-04-03
K161353	ESTELITE BULK FILL Flow	Tokuyama Dental Corporation	EBF	Class II	2017-04-03
K170783	Cx50n(cx50yqs)	Wide Corporation	PGY	Class II	2017-03-31
K170628	BioMonitor 2-AF, BioMonitor 2-S	BIOTRONIK AG	MXD	Class II	2017-03-31
K170622	Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component	Cook Incorporated	OQY	Class II	2017-03-31
K170449	Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection	Millennium Medical Technologies, Inc.	MUU	Class II	2017-03-31
K170284	Great Basin Bordetella Direct Test	Great Basin Scientific, Inc.	OZZ	Class II	2017-03-31
K170243	LOSPA IS TLIF & DLIF Cages	Corentec Co., Ltd.	MAX	Class II	2017-03-31
K170098	ICONIX TT All Suture Anchor	Stryker Corp.	MBI	Class II	2017-03-31
K163649	SureSigns VS3; SureSigns VS4	Philips North America LLC	DSJ	Class II	2017-03-31
K163350	Multibase Abutments EV and ATLANTIS Suprastructures	Dentsply Sirona Inc	NHA	Class II	2017-03-31
K163096	GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System	GPC Medical Limited	NKB	Class II	2017-03-31
K162873	MEP Monitor	Tonica Elektronik a/S	GWF	Class II	2017-03-31
K162820	AC3 Series IABP System	Arrow International LLC (subsidiary of Teleflex Incorporated)	DSP	Class II	2017-03-31
K162627	EnsoSleep	Ensodata, Inc.	OLZ	Class II	2017-03-31
K162626	Thermoplastic Polyethylene Examination (Tpe) Glove	Top Quality Glove Sdn. Bhd	LZA	Class I	2017-03-31
K162559	Move Forward 3D Motion Simulation Service	Zimmer GmbH	LLZ	Class II	2017-03-31
K162530	Multichem IA Plus	Techno-Path Manufacturing Ltd.	JJY	Class I	2017-03-31
K162413	AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System	STERIS Corporation	MLR	Class II	2017-03-31
K162309	StealthStation S8 System Platforms and StealthStation Cranial Software	Medtronic Navigation, Inc	HAW	Class II	2017-03-31
K162186	Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Sterling/grey] with Chemotherapy Claim	Brightway Holdings Sdn. Bhd.	LZC	Class I	2017-03-31
K162167	Caphosol Artifical Saliva Tablets	Eusa Pharma (Uk) Limited	LFD	Unclassified	2017-03-31
K161635	AMIStem-H Proximal Coating	Medacta International SA	LZO	Class II	2017-03-31
K161530	Bluetooth blood pressure monitor	Shenzhen Kingyield Technology Co., Ltd	DXN	Class II	2017-03-31
K161257	MultiPulse HoPLUS	Asclepion Laser Technologies GmbH	GEX	Class II	2017-03-31
K170743	AngioDynamics Total Abscession Biliary Drainage Catheter	Boston Scientific Corporation	FGE	Class II	2017-03-30
K170635	Chameleon PTA Balloon Catheter	Av Medical Technologies, Ltd.	LIT	Class II	2017-03-30
K170327	Parcus SLiK Anchors	Parcus Medical, L.L.C.	MBI	Class II	2017-03-30
K170310	Alians Clavicle range	Newclip Technics	HRS	Class II	2017-03-30
K170271	NuVasive(r) Monolith Corpectomy System	Nu Vasive, Incorporated	MQP	Class II	2017-03-30
K170077	LUOFUCON Silicone Ag Foam Dressing with Border	HuiZhou Foryou Medical Devices Co., Ltd.	FRO	Unclassified	2017-03-30
K170009	Esophageal Cooling Device	Advanced Cooling Therapy, LLC	PLA	Class II	2017-03-30
K162995	Ibis® Pedicle Screw System	Ortho Development Corp.	NKB	Class II	2017-03-30
K162471	Hach CM130 Chlorine Monitoring System	Hach Company	PSX	Class II	2017-03-30
K170654	USS System	Synthes (USA) Products LLC	NKB	Class II	2017-03-29
K170161	New Deantronics E Green™ Electrosurgical Monopolar Pencils	New Deantronics Taiwan Ltd.	GEI	Class II	2017-03-29
K163700	Bodycad Unicompartmental Knee System	Bodycad Laboratories, Inc.	HSX	Class II	2017-03-29
K163529	ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)	Avery Dennison Corporation	FRO	Unclassified	2017-03-29
K163052	Brevera Biopsy System with Corlumina Imaging Technology	Hologic, Inc.	KNW	Class II	2017-03-29
K162999	V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System	Terumo Cardiovascular Systems Corporation	HCG	Class II	2017-03-29
K162693	VertebraLINK Fusion Platform	Facetlink dba Linkspine	MAX	Class II	2017-03-29
K162124	Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins	DePuy Synthes	JDP	Class II	2017-03-29
K161929	Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove	Dipped Products (Thailand) Ltd	LZA	Class I	2017-03-29