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 562 of 3529

510(k) clearances, page 562 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K172038	Trocar	WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.	GCJ	Class II	2017-10-27
K172028	Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)	Gebauer Co	MLY	Unclassified	2017-10-27
K171979	Tubing Pack	Medtronic, Inc.	DWF	Class II	2017-10-27
K171926	C5 Diagnostic Ultrasound System	Guangzhou Sonostar Technologies Co., Ltd.	IYN	Class II	2017-10-27
K170585	Skylife	Neolight, LLC	LBI	Class II	2017-10-27
K170466	Automatic Blood Pressure Monitor Model LD-518 & LD-537	HONSUN (NANTONG) Co., Ltd.	DXN	Class II	2017-10-27
K170429	Tyvek Sterilization Pouches with Chevron Seal	Andersen Sterilizers, Inc.	FRG	Class II	2017-10-27
K170345	Softdiso	Best Nomos	IYE	Class II	2017-10-27
K162738	Puritan Bennett 980 Ventilator System	Medtronic, Inc.	CBK	Class II	2017-10-27
DEN170030	VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody	Ventana Medical Systems Inc	PZJ	Class II	2017-10-27
K173094	OrthoVision	Ewoosoft Co., Ltd	LLZ	Class II	2017-10-26
K173046	Cocoon Portable Handheld X-Ray System	Dexcowin Co., Ltd.	MUH	Class II	2017-10-26
K173022	SeaSpine Ventura NanoMetalene System	SeaSpine Orthopedics Corporation	MAX	Class II	2017-10-26
K172994	EPI K Console	Moria SA	HNO	Class I	2017-10-26
K172417	SILC® Fixation System	Globus Medical, Inc.	OWI	Class II	2017-10-26
K172341	NuVasive® Modulus TLIF Interbody System	Nu Vasive, Incorporated	MAX	Class II	2017-10-26
K172325	Rhapsody H-30 Holmium Laser System	Cook Incorporated	GEX	Class II	2017-10-26
K172323	Omnia Medical VBR	Omnia Medical	MQP	Class II	2017-10-26
K171931	Celerity ECG Cable Accessory Pack	Medcomp ( Medical Components)	LJS	Class II	2017-10-26
K171831	Intra-Lock Bone Fixation System	Intra-Lock International	DZL	Class II	2017-10-26
K171142	Healing Cap Multi-Unit Titanium	Nobel Biocare AB	NHA	Class II	2017-10-26
K173242	CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large)	Boston Scientific Corporation	FTM	Class II	2017-10-25
K173095	VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations	Medos International SARL	NKB	Class II	2017-10-25
K173031	AtriClip LAA Exclusion System with Preloaded PRO·V Clip	AtriCure, Inc.	FZP	Class II	2017-10-25
K172970	M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2017-10-25
K172937	Colorado Therapeutics Xenograft Implant	Colorado Therapeutics LLC	FTM	Class II	2017-10-25
K172808	CosmoLock Pedicle Screw System	Kalitec Direct, LLC	NKB	Class II	2017-10-25
K172626	Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir	Medtronic, Inc.	DTZ	Class II	2017-10-25
K172617	Treace Medical Concepts (TMC) Compression Screw System	Treace Medical Concepts, Inc.	HWC	Class II	2017-10-25
K172600	AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal	Alcon Laboratories	LPL	Class II	2017-10-25
K172455	CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit	Volcano Corporation	IYO	Class II	2017-10-25
K172334	Ortus™ Expandable Lumbar Interbody Fusion System	Atlas Spine, Inc.	MAX	Class II	2017-10-25
K172200	3880 MRI Patient Monitoring System	Iradimed Corporation	MWI	Class II	2017-10-25
K172132	CleanCision Wound Retraction and Protection System	Prescient Surgical	PQI	Class II	2017-10-25
K171946	Gel-Bead	Vascular Solutions LLC	KRD	Class II	2017-10-25
K171914	Cortina™ Lumbar Cage System	Neurostructures, Inc.	MAX	Class II	2017-10-25
K170454	Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U	HONSUN (NANTONG) Co., Ltd.	DXN	Class II	2017-10-25
K170423	DentureID Microchip	Cmp Industries, LLC	PYQ	Class II	2017-10-25
K170307	SunCHECK	Sun Nuclear Corporation	IYE	Class II	2017-10-25
K170293	Emit II Plus Cocaine Metabolite Assay	Siemens Healthcare Diagnostics Inc.	DIO	Class II	2017-10-25
K170226	iTotal Family Reusable Instrument Tray	ConforMIS, Inc.	KCT	Class II	2017-10-25
K163050	Advance Medical Designs, Inc. Sterile Ultrasound Gel	Advance Medical Designs Inc	MUI	Class II	2017-10-25
K162652	Smart Photon Micro-current Device, Model: EP-300	Li-Tek Electronic Technology Corporation	NFO	Class II	2017-10-25
K172951	Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)	Varex Imaging Corporation	MQB	Class II	2017-10-24
K172307	Dynamic Coronary Roadmap 2.0	Philips Medical Systems Nederland B.V.	OWB	Class II	2017-10-24
K172251	UTS Stem	United Orthopedic Corp.	LPH	Class II	2017-10-24
K172000	ClearLumen II Peripheral Thrombectomy System	Walk Vascular, LLC	QEZ	Class II	2017-10-24
K171751	SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module	Capsule Technologie SAS	MWI	Class II	2017-10-24
K171575	ENFLU 18 (enflufocon A) Daily Wear Contact Lens	Contamac Ltd.	HQD	Class II	2017-10-24
K170320	Alinity c ICT Sample Diluent	Abbott Medical	CGZ	Class II	2017-10-24