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 560 of 3529

510(k) clearances, page 560 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K173265	UltraVision 2 Diagnostic Ultrasound System	Winprobe Corporation	IYN	Class II	2017-11-07
K173086	NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses	Visioneering Technologies, Inc	LPL	Class II	2017-11-07
K173009	NCompass Nitinol Stone Extractors	Cook Incorporated	LQR	Class II	2017-11-07
K172446	SPIRA-C Open Matrix Cervical Interbody	Camber Spine Technologies	ODP	Class II	2017-11-07
K172392	Lateral Spinal Truss System (LSTS) Interbody Fusion Device	4WEB Inc.	MAX	Class II	2017-11-07
K172177	Insulia Diabetes Management Companion	Voluntis	NDC	Class II	2017-11-07
K171473	Compressyn™ Staple	Dallen Medical, Inc.	JDR	Class II	2017-11-07
K171365	Arthrex Knee Systems	Arthrex GmbH	MBH	Class II	2017-11-07
K171004	Hintermann Series H2 Total Ankle System	DT MedTech, LLC	HSN	Class II	2017-11-07
K170595	IV Administration Sets	B.Braun Medical, Inc.	FPA	Class II	2017-11-07
K170464	StatStrip Xpress Blood Glucose Monitoring System	Nova Biomedical Corporation	NBW	Class II	2017-11-07
K163694	Rooti Rx ECG Event Recorder, Rooti Link APP Software	Rooti Labs, Ltd.	DRG	Class II	2017-11-07
K172979	NuVasive® Growth Rod Conversion Set	Nu Vasive, Incorporated	PGM	Class II	2017-11-06
K172712	gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler	Gri Medical & Electronic Technology Co., Ltd.	FMK	Class II	2017-11-06
K172604	XW-100 Automated Hematology Analyzer for CLIA Waived Use	Sysmex America, Inc.	GKZ	Class II	2017-11-06
K172442	Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)	Hartalega NGC Sdn Bhd	LZA	Class I	2017-11-06
K172441	EPIC Extremity Fracture Plate System	Epic Extremity, LLC	HRS	Class II	2017-11-06
K172260	Omni Foot Plating System	Extremity Medical, LLC	HRS	Class II	2017-11-06
K163634	External Hex Implants	Southern Implants, (Pty.) Ltd.	DZE	Class II	2017-11-06
K172711	Comet-PLUS	Natus Medical Incorporated	OLV	Class II	2017-11-03
K172644	Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base	Stimwave Technologies Incorporated	GZB	Class II	2017-11-03
K172639	PALLAS 308/311 Solid-State UV Laser System	Laseroptek	GEX	Class II	2017-11-03
K172609	CSMC Cardiac Suite	Cedars Sinai Medical Center	KPS	Class II	2017-11-03
K172591	Fixed Patient Leads ECG Cable (Model 3153)	Boston Scientific Corporation	DSA	Class II	2017-11-03
K172277	Phlebo Press DVT Model	MEGO AFEK AC Ltd.	JOW	Class II	2017-11-03
K172060	Capio SLIM Suture Capturing Device	Boston Scientific Corporation	PWI	Class II	2017-11-03
K172054	Materialise Glenoid Positioning System	Materialise N.V.	KWS	Class II	2017-11-03
K172045	Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2	GE Healthcare	BSZ	Class II	2017-11-03
K171842	Geistlich Wound Matrix	Geistlich Pharma AG	KGN	Unclassified	2017-11-03
K171788	Reprocessed Halo XP Diagnostic Electrophysiology Catheter	Innovative Health, LLC.	NLH	Class II	2017-11-03
K170965	Fingertip Pulse Oximeter	Shenzhen Jumper Medical Equipment Co.,Ltd.	DQA	Class II	2017-11-03
K170897	Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site	B.Braun Medical, Inc.	PTI	Class II	2017-11-03
K173341	Vivid E80, Vivid E90, Vivid E95	GE Healthcare	IYN	Class II	2017-11-02
K173232	myMerlin(TM) Mobile Application Model APP1001	Abbott Medical	MXC	Class II	2017-11-02
K172757	Valleylab FX8 Electrosurgical Platform	Medtronic, Inc.	GEI	Class II	2017-11-02
K172674	Sapphire Cervical Implant System	Sapphire Medical Group	ODP	Class II	2017-11-02
K172437	CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System	Orthofix SRL	ODP	Class II	2017-11-02
K172407	Duracetal	Myerson LLC	EBI	Class II	2017-11-02
K172373	Compound W Nitro-Freeze	MedTech Products, Inc.	GEH	Class II	2017-11-02
K172328	SOVEREIGN™ Spinal System	Medtronic Sofamor Danek USA Inc	OVD	Class II	2017-11-02
K172301	Mako Partial Knee Application	Mako Surgical Corp.	OLO	Class II	2017-11-02
K171376	DynaNail TTC Fusion System	Medshape, Inc.	HSB	Class II	2017-11-02
K170853	InnoSpire Go	Respironics Respiratory Drug Delivery (Uk), Ltd.	CAF	Class II	2017-11-02
K170422	Biosoft Duo Double Loop Ureteral Stents	MEDLINE INDUSTRIES, LP - Northfield	FAD	Class II	2017-11-02
K170405	BD Curve Ascites Shunt	Care Fusion	KPM	Class II	2017-11-02
K170341	Medussa-PL Cage	Medyssey USA	MAX	Class II	2017-11-02
K170080	Neodent Implant System - CM Pro PEEK Abutment	JJGC Industria e Comercio de Materiais Dentarios SA	NHA	Class II	2017-11-02
K163646	Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator	Terragene LLC	FRC	Class II	2017-11-02
K163453	VitalPatch® VitalConnect Platform	VitalConnect, Inc.	DRG	Class II	2017-11-02
K163223	ORCA (tm) - Operational Rescue Containment Apparatus	Isovac Products LLC	LGM	Class II	2017-11-02