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 564 of 3529

510(k) clearances, page 564 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K171014	VICTUS Femtosecond Laser Platform	Technolas Perfect Vision GmbH	OOE	Class II	2017-10-19
K170614	CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System	I-SENS, Inc.	NBW	Class II	2017-10-19
K170453	Medrobotics Flex Robotic System	Medrobotics Corporation	EOB	Class II	2017-10-19
K170316	Alinity C Glucose Reagent Kit, Alinity C System	Abbott Medical	CFR	Class II	2017-10-19
K170261	Premium Plus Prophy Air Motor	Premium Plus International Limited	EFB	Class I	2017-10-19
K162216	Gri-Fill Peristaltic Set	Laboratorios Grifols, S.A.	LHI	Class II	2017-10-19
K173101	Curve Image 2.0 PACS	Curve Dental, Inc.	LLZ	Class II	2017-10-18
K172940	ANCHOR Tissue Retrieval System	ConMed Corporation	GCJ	Class II	2017-10-18
K172910	Emit II Plus Oxycodone Assay	Siemens Healthcare Diagnostics Inc.	DJG	Class II	2017-10-18
K172809	OTC Combo TENS/EMS System	Well-Life Healthcare Limited	NUH	Class II	2017-10-18
K172801	ECG SENTINEL System	Cardiomedix, Inc.	DXH	Class II	2017-10-18
K172608	Medline ReNewal Reprocessed Stryker SERF AS Energy Probes	Medline ReNewal	NUJ	Class II	2017-10-18
K172297	NovaCross Microcatheter	Nitiloop, Ltd.	DQY	Class II	2017-10-18
K172203	CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray	Nuance Medical, LLC	MLY	Unclassified	2017-10-18
K172034	Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap	Stryker Corp.	OLO	Class II	2017-10-18
K171579	M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2017-10-18
K171125	Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens	TANGIBLE SCIENCE Inc	LPL	Class II	2017-10-18
K171068	OrthoView 7.2	Meridian Technique Ltd	LLZ	Class II	2017-10-18
K171017	Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T	Convaid Products LLC	IOR	Class I	2017-10-18
K170298	Liberator Beacon Tip Locking Stylet	Cook Incorporated	DRB	Class II	2017-10-18
K172817	4K Camera Head Olympus Ch-S400-Xz-Eb, 4K Autoclavable Camera Head Olympus Ch-S400-Xz-Ea	Olympus Medical Systems Corp.	FET	Class II	2017-10-17
K172806	Bencox Mirabo Cup System	Corentec Co., Ltd.	LPH	Class II	2017-10-17
K172728	Applanation tonometer AT-1	Takagi Seiko Co., Ltd.	HKY	Class II	2017-10-17
K172493	EnsoETM	Attune Medical	PLA	Class II	2017-10-17
K172198	585	Quanta System Inc.	GEX	Class II	2017-10-17
K172179	Chitogel Endoscopic Sinus Surgery Kit	Chitogel Limited	LYA	Class I	2017-10-17
K171752	X-Surge	Genicon, Inc.	GEI	Class II	2017-10-17
K170834	Cerabien Zr	Kuraray Noritake Dental, Inc.	EIH	Class II	2017-10-17
K170538	RVS-100 Vital Signs Monitor	Rudolf Riester GmbH	MWI	Class II	2017-10-17
K160282	SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System	SD Biosensor, Inc.	NBW	Class II	2017-10-17
K172537	Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag	Cerenovus, Inc.	JXG	Class II	2017-10-16
K172487	Coaxial Dilator Set (Micro-Introducer)	Galt Medical Corp	DRE	Class II	2017-10-16
K172186	BioWick X Implant with Driver	Cayenne Medical Inc.	MBI	Class II	2017-10-16
K171974	Solana RSV+hMPV Assay	Ortho-Clinical Diagnostics, Inc.	OCC	Class II	2017-10-16
K171879	HylaGuard Moisturizing Cream	Founders Science Group, LLC	MGQ	Unclassified	2017-10-16
K170948	AcQMap High Resolution Imaging and Mapping System	Acutus Medical, Inc.	DQK	Class II	2017-10-16
K170819	AcQMap 3D Imaging and Mapping Catheter	Acutus Medical, Inc.	MTD	Class II	2017-10-16
K162042	OptiScanner 5000 Glucose Monitoring System	Optiscan Biomedical Corp.	LZF	Class II	2017-10-16
K172784	DX-D Imaging Package	AGFA Healthcare Corp.	MQB	Class II	2017-10-13
K172772	Freemie Independence, Freemie Liberty	Dao Health	HGX	Class II	2017-10-13
K172498	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y	Microlife Intellectual Property GmbH	DXN	Class II	2017-10-13
K172454	Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL	Thermo Fisher Scientific Oy	JWY	Class II	2017-10-13
K172435	Galaxy R Digital Radiography Upgrade	Medien International Co, Ltd.	MQB	Class II	2017-10-13
K172197	SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS	CooperSurgical, Inc.	MQL	Class II	2017-10-13
K172181	micro IPL	El Global Trade Ltd.	OHT	Class II	2017-10-13
K172023	Celfirm	VIOL Co., Ltd.	GEI	Class II	2017-10-13
K171916	Single Use Hot Biopsy Forceps FD-231	Olympus Medical Systems Corp.	KGE	Class II	2017-10-13
K171702	Exciplex308nm	Clarteis	FTC	Class II	2017-10-13
K171548	Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter	Wilson-Cook Medical Inc.	FGE	Class II	2017-10-13
K171286	PAL Multi-Use Cannulas and PAL Manual Wand	MicroAire Surgical Instruments, LLC	QPB	Class II	2017-10-13