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 716 of 3530

510(k) clearances, page 716 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K150235	CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels	Boston Scientific Corporation	DRQ	Class II	2015-04-22
K150108	Reverse Medical Micro Vascular Plug System	Reverse Medical Corporation	KRD	Class II	2015-04-22
K143541	Relieva SpinPlus Balloon Sinuplasty System	Acclarent Inc	LRC	Class I	2015-04-22
K143363	VENUS Spinal Fixation System	L&K Biomed Co.,Ltd.	NKB	Class II	2015-04-22
K143034	Jintronix	Jintronix Inc.	LXJ	Class II	2015-04-22
K142058	Rayscan a-Expert	Ray Co., Ltd.	MUH	Class II	2015-04-22
K141999	Advia Centaur Tsh	Siemens Healthcare Diagnostics Inc.	JLW	Class II	2015-04-22
K141770	Luna CPAP and Auto-CPAP System	3B Medical Inc	BZD	Class II	2015-04-22
K150499	Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty	Medela AG	HGX	Class II	2015-04-21
K150134	Basic, Dominant Flex, KV-6	Medela AG	QPB	Class II	2015-04-21
K143574	Melodi Prime Breast Pump	Genadyne Biotechnologies, Inc.	HGX	Class II	2015-04-21
K143341	Microlife Upper Arm Automatic Digital Blood Pressure Monitor	Microlife Intellectual Property GmbH	DXN	Class II	2015-04-21
K143312	Portrait GBS Assay	Great Basin Corporation	NJR	Class I	2015-04-21
K142994	IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers	Immunodiagnostic Systems Ltd.	CJM	Class II	2015-04-21
K142216	Tranberg CLS Thermal Therapy System	Clinical Laserthermia Systems AB	GEX	Class II	2015-04-21
K150897	Tosama 100% Cotton Menstrual Tampon	TOSAMA d.o.o.	HEB	Class II	2015-04-20
K150212	DeScribe Transparent PFD Patch	On Light Sciences, Inc.	PKO	Class II	2015-04-20
K150133	PROFEMUR Preserve Size 1-3 Hip Stems	Microport Orthopedics Inc.	LZO	Class II	2015-04-20
K150033	Air Compressible Limb Therapy System	Daesung Maref Co.,Ltd	IRP	Class II	2015-04-20
K143739	POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA	Smith & Nephew, Inc.	LZO	Class II	2015-04-20
K143527	IPM Wound Gel Bio, IPM Derm Gel Bio	Glycobiosciences, Inc.	FRO	Unclassified	2015-04-20
K143440	Natus Quantum	Natus Medical Incorporated	GWQ	Class II	2015-04-20
K143140	G-Premio BOND	GC America Inc.	KLE	Class II	2015-04-20
K143016	Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home	Cardinalhealth	OMP	Class II	2015-04-20
K142506	TensCare KegelFit	Tenscare Ltd.	KPI	Class II	2015-04-20
K142163	Male Circumcision Kits:rapideclamp	Medicfit Technology Sdn Bhd	HFX	Class II	2015-04-20
K141747	Rhinoguard	Davis Medical	BTR	Class II	2015-04-20
K132663	I-Qare Ds-W Blood Glucose Monitoring System	Alliance International Corp. Ltd.	NBW	Class II	2015-04-20
K150714	SI-BONE iFuse Implant System	SI-Bone, Inc.	OUR	Class II	2015-04-17
K150490	UnicLine Mobile	Heka Dental A/S	EIA	Class I	2015-04-17
K150430	Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor	Fudakang Industrial Co Ltd	DXN	Class II	2015-04-17
K150427	Vantage Titan 1.5T, V3.1, MRT-1510	Toshibamedical Systems Corporation	LNH	Class II	2015-04-17
K150416	ProCinch Adjustable Loop Device	Stryker Corp.	HTY	Class II	2015-04-17
K150191	GammaBeam 500	Best Theratronics Ltd.	IWB	Class II	2015-04-17
K150104	Vitrea CT Myocardial Perfusion	Canon Medical Informatics, Inc.	JAK	Class II	2015-04-17
K143599	Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000	Chemtron Biotech, Inc.	DJG	Class II	2015-04-17
K143447	Dilapan-S	Medicem Technology s.r.o	PKN	Class II	2015-04-17
K142986	SagiNova	Eckert & Ziegler Bebig GmbH	JAQ	Class II	2015-04-17
K142930	Exam Vue DR	JPI Healthcare Co., Ltd	KPR	Class II	2015-04-17
K142883	MindChild Meridian M100 Fetal Heart Rate Monitor	Mindchild Medical	HGM	Class II	2015-04-17
K142779	Scanip; Scanip: Medical Edition; Scanip: Med	Simpleware, Ltd.	LLZ	Class II	2015-04-17
K142247	Rayscan a-Expert 3D	Ray Co., Ltd.	OAS	Class II	2015-04-17
K142186	Diode Laser Hair Removal System	Shenzhen GSD Tech Co., Ltd	GEX	Class II	2015-04-17
K142149	Oxytote Infinity Series Vipr Systems	Western Enterprises, Inc.	ECX	Class I	2015-04-17
K142083	True Flow Valvuloplasty Perfusion Catheter	C.R. Bard Inc	OZT	Class II	2015-04-17
K141827	Euroimmun Ifa 40: Hep-20-10; Europattern Microscope and Software	Euroimmun US Inc.	DHN	Class II	2015-04-17
K140506	Joy Drops (Tm) Natural Personal Lubricant Gel	Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa	NUC	Class II	2015-04-17
K140453	Osteotec Silicone Finger Implant	Osteotec Limited	KYJ	Class II	2015-04-17
K150860	Nitroglycerin Sets with DUO-VENT Spike	Baxter Healthcare Corporation	FPA	Class II	2015-04-16
K150660	Alcyone MEMS Cannula (AMC) System	Alcyone Lifesciences, Inc.	HCD	Class I	2015-04-16