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 561 of 3529

510(k) clearances, page 561 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K163087	PixoTest Blood Glucose Monitoring System	Ixensor Co Ltd	NBW	Class II	2017-11-02
K173175	Paramount Anterior Cervical Cage System	Spine Wave Inc	OVE	Class II	2017-11-01
K172649	Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor	Heidelberg Engineering GmbH	OBO	Class II	2017-11-01
K172347	GMK Hinge, GMK Revision	Medacta International SA	KRO	Class II	2017-11-01
K172144	CoolSculpting System	Zeltiq Aesthetics Inc	OOK	Class II	2017-11-01
K171580	Monitor B125, Monitor B105	GE Medical Systems China Co., Ltd.	MHX	Class II	2017-11-01
K171370	IMAGEnet 6 Ophthalmic Data System	Topcon Corp.	NFJ	Class II	2017-11-01
K171026	Mytens Model: BW-TSX	Bewell Connect Corp.	NUH	Class II	2017-11-01
K170767	Surgical Stainless Steel Suture, Stainless Steel Suture	Ethicon, Inc	GAQ	Class II	2017-11-01
K170513	MAUSER PG II Sharps Container	Mauzer USA, LLC	MMK	Class II	2017-11-01
K170439	AN87 Dosimeter	Andersen Sterilizers, Inc.	JOJ	Class II	2017-11-01
K170437	Sterisheet Sterilization Wrap	Andersen Sterilizers, Inc.	FRG	Class II	2017-11-01
K170353	ABX MICROS ES 60 OT and ABX MICROS ES 60 CT	Horiba Abx SAS	GKZ	Class II	2017-11-01
K162812	Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set	Unomedical A/S	FPA	Class II	2017-11-01
K173318	Rapid HB, Rapid LB, Rapid MB	3M Deutschland GmbH	ELW	Class II	2017-10-31
K173080	IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)	Huvexel Co., Ltd.	MAX	Class II	2017-10-31
K172572	Stryker Upper-Face AXS screws and Mid-Face AXS screws	Stryker Corp.	JEY	Class II	2017-10-31
K172447	JO Gelato Flavored Personal Lubricants	United Consortium	NUC	Class II	2017-10-31
K172333	Sysmex CS-5100	Siemens Healthcare Diagnostics Products Limited	JPA	Class II	2017-10-31
K172268	iFuse Implant System- iFuse Navigation	SI-Bone, Inc.	OLO	Class II	2017-10-31
K171767	Cianna Medical SAVI Scout Reflector and SAVI Scout System	Cianna Medical, Inc.	NEU	Class II	2017-10-31
K171708	Aloka Arietta 850	FUJIFILM Healthcare Americas Corporation	IYN	Class II	2017-10-31
K170432	Anprolene AN75 Ethylene Oxide Gas Sterilizer	Andersen Sterilizers, Inc.	FLF	Class II	2017-10-31
K170427	Anprolene SteriTest	Andersen Sterilizers, Inc.	FRC	Class II	2017-10-31
K170359	Trinity™ Dual Mobility System	Corin USA	LZO	Class II	2017-10-31
K172943	Flex-Thread Fibula Pin System	Intrafuse, LLC	HSB	Class II	2017-10-30
K172646	XIDF-AWS801, Angio Workstation, V7.0	Toshibamedical Systems Corporation	OWB	Class II	2017-10-30
K172404	SenoBright HD	GE Healthcare	MUE	Class II	2017-10-30
K172402	ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit	Luminex Corporation	PGX	Class II	2017-10-30
K172351	AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert	Encore Medical, LP	KWS	Class II	2017-10-30
K172326	Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System	Stryker Orthopaedics	JWH	Class II	2017-10-30
K172296	Stethee Pro	M3Dicine Pty, Ltd.	DQD	Class II	2017-10-30
K172236	Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled	Avinger, Inc.	MCW	Class II	2017-10-30
K171643	Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed	Geistlich Pharma AG	NPL	Class II	2017-10-30
K171525	Intellijoint HIP Generation 2B System	Intellijoint Surgical Inc.	OLO	Class II	2017-10-30
K171008	Anorganic Bone Mineral with Collagen in Delivery Applicator	Collagen Matrix, Inc	NPM	Class II	2017-10-30
K170917	Bi-Ostetic Bioactive Glass Foam	Berkeley Advanced Biomaterials	MQV	Class II	2017-10-30
K170426	AN85/AN86 EO Indicators	Andersen Sterilizers, Inc.	JOJ	Class II	2017-10-30
K163659	Crystal Vision	I.C. Medical, Inc.	FYD	Class II	2017-10-30
K173184	Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle	Boston Scientific Corporation	ODG	Class II	2017-10-27
K173138	Biim Diagnostic Ultrasound System	Biim Ultrasound AS	IYO	Class II	2017-10-27
K173132	ASPIRE Cristalle	FUJIFILM Healthcare Americas Corporation	MUE	Class II	2017-10-27
K173122	Abbott Architect Free T4	Abbott Medical	CEC	Class II	2017-10-27
K173104	Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly	Total Joint Orthopedics, Inc.	OQG	Class II	2017-10-27
K172815	2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)	Shenzhen Beacon Display Technology Co., Ltd.	PGY	Class II	2017-10-27
K172803	Infinitt PACS 7.0	Infinitt Healthcare Co., Ltd.	LLZ	Class II	2017-10-27
K172534	LINACwatch, LinacView	Qualiformed SARL	IYE	Class II	2017-10-27
K172133	ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay	Axis-Shield Diagnostics, Ltd.	CDD	Class II	2017-10-27
K172087	Sangray	Hitachi, Ltd.	MOT	Unclassified	2017-10-27
K172077	Cutera enlighten III Laser System	Cutera Inc	GEX	Class II	2017-10-27