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 690 of 3530

510(k) clearances, page 690 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K152003	iHealth BP3L Wireless Blood Pressure Monitor	Andon Health Co., Ltd	DXN	Class II	2015-09-24
K151786	Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet	Roche Diagnostics GmbH	CDD	Class II	2015-09-24
K151592	Gemmed pedicle screw spinal system	Suzhou Gemmed Medical Instrument Co., Ltd.	MNI	Class II	2015-09-24
K151293	Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis	Tornier S.A.S.	KWS	Class II	2015-09-24
K151151	U & U Intravascular Administration Set	U&u Medical Technology Co., Ltd	FPA	Class II	2015-09-24
K150650	neon3	Ulrich GmbH & Co. KG	NKG	Class II	2015-09-24
K152440	Sydney IVF PVP	Willam A. Cook Australia Pty, Ltd.	MQL	Class II	2015-09-23
K152407	Infinity Delta, Infinity Delta XL, Infinity Kappa	Draeger Medical Sytems, Inc.	MHX	Class II	2015-09-23
K152379	iHealth View BP7S Wireless Blood Pressure Wrist Monitor	Andon Health Co., Ltd	DXN	Class II	2015-09-23
K152317	Stretta Catheter	Curon Medical, Inc.	GEI	Class II	2015-09-23
K152072	CrossRoads Screw System	Crossroads Extremity Systems LLC	HWC	Class II	2015-09-23
K151742	Contour Next Control Solution	Medrad, Inc.	JJX	Class I	2015-09-23
K151647	Uberlube	Uberlube	NUC	Class II	2015-09-23
K151637	UPT Series Medical RO Water System	Specialty Water Technologies, Inc.	FIP	Class II	2015-09-23
K151306	Solea	Convergent Dental	GEX	Class II	2015-09-23
K143736	ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA	Immco Diagnostics, Inc.	DHR	Class II	2015-09-23
K143685	Hedgehog Cervical Interbody Fusion Device	Vertera, Inc.	ODP	Class II	2015-09-23
K152403	Permanent Sled Bag	Boston Scientific Corporation	ITX	Class II	2015-09-22
K151951	Destino Reach	Oscor Inc.	DYB	Class II	2015-09-22
K151179	ZELTIQ CoolSculpting System	Zeltiq Aesthetics Inc	OOK	Class II	2015-09-22
K150987	HEARTWAY Power Mobility Scooter, BRIO S19	Heartway Medical Products Co., Ltd.	INI	Class II	2015-09-22
K150532	Universal Light Handle Cover, Light Handle Cover	Key Surgical, LLC	FTA	Class II	2015-09-22
K152469	ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System	Siemens Medical Solutions, Inc., Ultrasound Division	IYN	Class II	2015-09-21
K152408	Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack	DiaSorin Molecular LLC	OCC	Class II	2015-09-21
K152404	Hi-Torque Command 18 Guide Wire	Abbott Vascular	DQX	Class II	2015-09-21
K152383	Ceramill Zolid FX	Emergo Europe Consulting	EIH	Class II	2015-09-21
K152218	AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System	Osprey Medical, Inc.	DXT	Class II	2015-09-21
K151830	Hummingbird Tympanostomy Tube	Preceptis Medical, Inc	ETD	Class II	2015-09-21
K151774	CARESTREAM Vue Motion	Eastman Kodak Company	LLZ	Class II	2015-09-21
K151678	Chameleon PTA Balloon Catheter	Av Medical Technologies, Ltd.	LIT	Class II	2015-09-21
K151564	Telio CAD Abutment Solutions	Ivoclar Vivadent, Inc.	NHA	Class II	2015-09-21
K151514	Prestige	Danville Materials, Inc.	EBF	Class II	2015-09-21
K151313	ZelanteDVT Thrombectomy Set	Boston Scientific Corporation	QEW	Class II	2015-09-21
K151262	Hyflex Heavy, Hyflex Mono, Hyflex Light	OSSTEM Implant Co., Ltd.	ELW	Class II	2015-09-21
K151195	OsteoMed IMF Screw	Osteomed	DZL	Class II	2015-09-21
K150657	Phoenix XL Dialysate Meter	Mesa Laboratories Inc	FIZ	Class II	2015-09-21
K143754	QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3	Inova Diagnostics, Inc.	NHX	Class II	2015-09-21
K142557	Anker Dental Implant System - SB-III, ST and AT series	Alliance Global Technology Co., Ltd.	DZE	Class II	2015-09-21
K142349	TM eCloud ECG Analysis System	Telemed Solutions, Inc.	DQK	Class II	2015-09-21
K152393	Eclipse Treatment Planning System	Varian Medical Systems, Inc.	MUJ	Class II	2015-09-18
K152335	Export Advance Aspiration Catheter	Medtronic, Inc.	DXE	Class II	2015-09-18
K152316	iLab Ultrasound Imaging System	Boston Scientific Corporation	IYO	Class II	2015-09-18
K152190	Thoratec CentriMag Drainage (Venous) Cannula Kit	Abbott Medical	DWF	Class II	2015-09-18
K152161	Thoratec CentriMag Return (Arterial) Cannula Kit	Abbott Medical	DWF	Class II	2015-09-18
K151979	STARband, STARlight	Orthomerica Products, Inc.	OAN	Class II	2015-09-18
K151728	CoStorSol plus G	Preservation Solutions Inc	KDN	Class II	2015-09-18
K151684	Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue)	Hartalega NGC Sdn Bhd	LZA	Class I	2015-09-18
K151518	Brush&bond Plus	Parkell, Inc.	KLE	Class II	2015-09-18
K151446	Recovr Rehabilitation System	Recovr,Inc	LXJ	Class II	2015-09-18
K151392	Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less	Terang Nusa (Malaysia) Sdn. Bhd.	KGO	Class I	2015-09-18