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 665 of 3530

510(k) clearances, page 665 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K152681	iFuse Implant System(R)	SI-Bone, Inc.	OUR	Class II	2016-03-01
K151905	3400E series; E5400 series; E6400 series; Sundazzler series	Heartland Tanning, Inc.	LEJ	Class II	2016-03-01
K150789	Spinaut-E, Spinaut-I	Imedicom Co., Ltd.	BSO	Class II	2016-03-01
K143482	xevonta dialyzer	B. Braun Avitum AG	KDI	Class II	2016-03-01
K160317	syngo.via MI Workflows	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2016-02-29
K153199	Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack	KCI USA, Inc.	OMP	Class II	2016-02-29
K152932	BlastGen	CooperSurgical, Inc.	MQL	Class II	2016-02-29
K150597	ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite	Phadia AB	DHB	Class II	2016-02-29
K150468	Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs	K2 Medical GmbH & Co. KG	HAE	Class II	2016-02-29
K160392	Novilase Laser Therapy System, Model LTS-2	Novian Health Inc.	GEX	Class II	2016-02-26
K160182	LOGIQ S7 Expert	GE Healthcare	IYN	Class II	2016-02-26
K160173	Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)	Boston Scientific Corporation	DXK	Class II	2016-02-26
K160171	Illuminated Mediastinal Access Port	Aegis Surgical, Ltd.	EWY	Class II	2016-02-26
K160003	Sniper (R) Spine System	Spine Wave Inc	MNI	Class II	2016-02-26
K153575	Tyber Medical Trauma Screw	Tyber Medical	HWC	Class II	2016-02-26
K153424	E-CUBE i7	ALPINION MEDICAL SYSTEMS Co., Ltd.	IYN	Class II	2016-02-26
K153295	TandemLung Oxygenator	Cardiacassist, Inc.	DTZ	Class II	2016-02-26
K153275	Aingeal Activity System	Intelesens Limited	MHX	Class II	2016-02-26
K153191	Calcium Bridge	Denali Corporation	EBF	Class II	2016-02-26
K152894	Vivix-S 1717N	Vieworks Co., Ltd.	MQB	Class II	2016-02-26
K152855	Vivix-S 1012N	Vieworks Co., Ltd.	MQB	Class II	2016-02-26
K152765	Venatech Convertible Vena Cava Filter System	B. BRAUN INTERVENTIONAL SYSTEMS Inc.	DTK	Class II	2016-02-26
K152626	H3+ Holter Recorder	Mortara Instrument, Inc.	MWJ	Class II	2016-02-26
K152416	Indego	Parker Hannifin Corp.	PHL	Class II	2016-02-26
K152082	Vesocclude Polymer Ligating Clip	Vesocclude Medical, LLC	FZP	Class II	2016-02-26
K151743	THUNDERBEAT Open Fine Jaw	Olympus Medical Systems Corp.	GEI	Class II	2016-02-26
K151482	BCR-30-min BI™ and RBIP-ST30™ Readout Accessory	Bcr Diagnostics, Inc.	FRC	Class II	2016-02-26
K151476	Beactive Brace	Natures Pillows, Inc.	PMV	Class I	2016-02-26
K151307	ICONACY(TM) I-Hip (TM)	Iconacy Orthopedic Implants, LLC	LZO	Class II	2016-02-26
K160328	DIVA ZSP2105CMI with QUBYX PerfectLum bundle	The Linden Group Corp.	PGY	Class II	2016-02-25
K160184	Voluson S6, Voluson S8, Voluson S10	GE Healthcare	IYN	Class II	2016-02-25
K160164	BD Veritor System for Rapid Detection of Flu A + B Labratory Kit	Becton Dickinson & Co	PSZ	Class II	2016-02-25
K160063	McLaren Proton Therapy System	McLaren Health Care	LHN	Class II	2016-02-25
K153759	SIGN Compression Screw System	SIGN Fracture Care International	HWC	Class II	2016-02-25
K153677	The Cellfina System	Merz North America, Inc.	OUP	Class II	2016-02-25
K153617	OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)	Boston Scientific Corporation	OBJ	Class II	2016-02-25
K153570	Axxent Electronic Brachytherapy System Model 110 XP 1200	iCAD, Inc.	JAD	Class II	2016-02-25
K153488	Occlusion Perfusion Catheter	Advanced Catheter Therapies, Inc.	QEY	Class II	2016-02-25
K153443	ASAHI Astato XS 40	Asahi Intecc Co., Ltd.	DQX	Class II	2016-02-25
K153135	Vital Signs Monitor	Guangdong Biolight Meditech Co., Ltd	MWI	Class II	2016-02-25
K153091	Implant 3D	Media Lab S.p.A.	LLZ	Class II	2016-02-25
K152989	Mammotome revolve Dual Vacuum Assist Biopsy System	Devicor Medical Products Inc	KNW	Class II	2016-02-25
K152736	Skin Care	C.I.S, Ltd.	GEX	Class II	2016-02-25
K152715	Haining Nitrile Powder Free Patient Examination Gloves, Blue Color	Haining Medical Products Co., Ltd.	LZA	Class I	2016-02-25
K152691	EDS Universal Cement	Essential Dental Systems, Inc.	EMA	Class II	2016-02-25
K152593	Latex Examination Glove Powder Free	Careplus (M) Sdn Bhd	LYY	Class I	2016-02-25
K152438	ETView VivaSight-SL (TVT) system	Etview, Ltd.	BTR	Class II	2016-02-25
K152332	Perfectio LED infrared device	Omm Imports, Inc. D/B/a Zero Gravity	OHS	Class II	2016-02-25
K152141	High Pressure Tanning Lamps	Blv Licht-Und Vakuumtechnik GmbH	LEJ	Class II	2016-02-25
K151866	BD BACTEC Peds Plus/F Culture Vials (plastic)	Becton Dickinson & Co	MDB	Class I	2016-02-25