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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 443 of 3528

510(k) clearances, page 443 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K192434	DualX Lumbar Intervertebral Body Fusion Device	Amplify Surgical	MAX	Class II	2019-10-15
K192194	TotalShield II Surgical Helmet System	Zimmer Surgical SA	FYA	Class II	2019-10-15
K191672	NuFACE Mini Device	Carol Cole Company dba NuFACE	NFO	Class II	2019-10-15
K191326	Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module	Arthrex GmbH	HRS	Class II	2019-10-15
K191251	Infared Thermometer	Shenzhen Calibeur Industries Co., Ltd.	FLL	Class II	2019-10-15
K190840	Medtronic Transportation / Sterilization Cassettes	Medtronic Sofamor Danek USA Inc	KCT	Class II	2019-10-15
K190149	Vial Adapter Ø20 mm	Avenir Performance Europeenne Medical (Apem)	LHI	Class II	2019-10-15
K190937	Echelon Endopath Staple Line Reinforcement	Ethicon Endo-Surgery Inc	OXC	Class II	2019-10-14
K192515	BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20	Shenzhen Bioeasy Biotechnology Co., Ltd.	LDJ	Class II	2019-10-11
K192312	Zimmer Natural Nail System Cephalomedullary Nails	Zimmer GmbH	HSB	Class II	2019-10-11
K192235	AEON Laparoscopic Instruments	Lexington Medical, Inc.	GEI	Class II	2019-10-11
K192214	CarboClear VBR System	CarboFix Orthopedics Inc.	MQP	Class II	2019-10-11
K192057	K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall	Terumo Europe N.V.	FMI	Class II	2019-10-11
K191902	Razor, Everest, U&C Liquid	U&c International Co., Ltd.	EIH	Class II	2019-10-11
K191822	Nano FortiCore, FortiCore	Nanovis, LLC	ODP	Class II	2019-10-11
K191684	MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System	Integra LifeSciences Corporation	JXG	Class II	2019-10-11
K191548	Nexus Universal Self-Cure	Sybron Dental Specialties, Inc.	EMA	Class II	2019-10-11
K191542	Apyx Plasma/RF Handpiece	Bovie Medical Corporation dba Apyx Medical Corporation	GEI	Class II	2019-10-11
K191480	Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)	Trigg Laboratories, Inc. D/B/A Wet International	NUC	Class II	2019-10-11
K191420	Reusable SpO2 Sensor	Shenzhen Changke Connect Electronics Co., Ltd.	DQA	Class II	2019-10-11
K191208	Spectra Cashmere	Uzinmedicare Co., Ltd.	HGX	Class II	2019-10-11
K191181	NXPRO Neuromuscular Electrical Stimulation Device	Neux Technologies, Inc.	NGX	Class II	2019-10-11
K190713	F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)	Fisher & Paykel Healthcare, Inc.	BZD	Class II	2019-10-11
K190084	McLean-Ring Enteral Feeding Tube Set	Cook Incorporated	KNT	Class II	2019-10-11
K183681	Protego Antimicrobial Wound Dressing	Global Health Solutions (dba Turn Therapeutics)	FRO	Unclassified	2019-10-11
K183674	Electronic Pulse Stimulator	Shenzhen Leading Perfection Technology Co., Ltd.	NUH	Class II	2019-10-11
K183589	PMT Facet Screw	Providence Medical Technology, Inc.	MRW	Unclassified	2019-10-11
K192526	Spine Wave Navigated Instruments	Spine Wave Inc	OLO	Class II	2019-10-10
K192474	Vera	Reflexion Health, Inc.	LXJ	Class II	2019-10-10
K192465	DigiFix Sterile Kit	Virak Orthopedics LLC	JEC	Class II	2019-10-10
K192210	ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System	Fiab SpA	FLL	Class II	2019-10-10
K192147	Halyard ONE-STEP* Sterilization Wrap	Owens & Minor (O&M) Halyard, Inc.	FRG	Class II	2019-10-10
K191963	SMR Finned Short Stems	Lima Corporate S.p.A.	MBF	Class II	2019-10-10
K191659	Instylla Delivery Kit	Instylla, Inc.	FMF	Class II	2019-10-10
K191458	Legacy SMARTBase Abutments	Implant Direct Sybron Manufacturing LLC	NHA	Class II	2019-10-10
K191417	Belun Ring	Belun Technology Company Limited	DQA	Class II	2019-10-10
K191174	Mercy babyTAPE	Children'S Mercy Hospital	PIR	Class I	2019-10-10
K191010	Palladium High Flow Therapy System	Vapotherm Inc.	BTT	Class II	2019-10-10
K190772	SURGICAL MICROSCOPE SYSTEM ORBEYE with IR	Olympus Medical Systems Corp.	IZI	Class II	2019-10-10
K190523	Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial	Ossdsign	PJN	Class II	2019-10-10
K190386	KTA Adipose Treatment Kit	Stemics S.A.S	MUU	Class II	2019-10-10
K190319	Waterlase Laser System Family	Biolase, Inc.	GEX	Class II	2019-10-10
K182184	Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)	MDK (Shanghai) Medical Packing Co., Ltd	FRG	Class II	2019-10-10
K182136	Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)	Shenzhen Osto Technology Company Limited	NUH	Class II	2019-10-10
DEN190025	OraQuick Ebola Rapid Antigen Test	OraSure Technologies, Inc.	QID	Class II	2019-10-10
K192208	CORNICE Cervical Spacer System	Legend Spine Technologies	ODP	Class II	2019-10-09
K192200	DynaCAD	Invivo Corporation	LLZ	Class II	2019-10-09
K192185	The Cellfina System	Merz North America, Inc.	OUP	Class II	2019-10-09
K191783	Parcus Synd-EZ Ti	Parcus Medical, L.L.C.	MBI	Class II	2019-10-09
K191687	pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire	Phenox Inc	DQX	Class II	2019-10-09