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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 389 of 3528

510(k) clearances, page 389 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K193449	Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)	Guangdong Horigen Mother & Baby Products Co., Ltd.	HGX	Class II	2020-09-11
K193340	GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System	Microtech Medical, Inc.	NBW	Class II	2020-09-11
K192137	IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550	Philips Medizin Systeme Boeblingen GmbH	MHX	Class II	2020-09-11
K191639	TK Insulin Syringe with/without Saftey Retractable Device	Anhui Tiankang Medical Technology Co., Ltd.	MEG	Class II	2020-09-11
K202242	HS Fiber	Riverpoint Medical, LLC	GAT	Class II	2020-09-10
K202156	Diamond-5A/6a/8a	DRGEM Corporation	KPR	Class II	2020-09-10
K202008	Disposable Vinyl Glove	Best Care Trading Co., Ltd.	LYZ	Class I	2020-09-10
K201944	DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)	Synthes (USA) Products LLC	JEY	Class II	2020-09-10
K201909	RxSight Contact Lens	RxSight Inc.	HJK	Class II	2020-09-10
K201738	SubNovii Advanced Plasma Technology	Cartessa Aesthetics	GEI	Class II	2020-09-10
K201731	Diode Laser Body Sculpture System	Shanghai Apolo Medical Technology Co.,Ltd.	PKT	Class II	2020-09-10
K201450	Straight T Clear Dental Aligner	Straight T, Inc.	NXC	Class II	2020-09-10
K201407	CD Horizon™ Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2020-09-10
K201330	Tigereye CTO-Crossing Catheter	Avinger, Inc.	PDU	Class II	2020-09-10
K201145	X-Pac Expandable Lumbar Cage System	Expanding Innovations, Inc.	MAX	Class II	2020-09-10
K200845	Navigation Module of the Momentum System	ulrich medical USA Inc	OLO	Class II	2020-09-10
K200135	RGK Daily Range Wheelchairs	RGK Wheelchairs, Ltd.	IOR	Class I	2020-09-10
K193212	DSM Biomedical Dental Bone Graft Plus	DSM Biomedical, Inc.	NPM	Class II	2020-09-10
K202256	3Shape Implant Studio	3Shape Medical A/S	LLZ	Class II	2020-09-09
K202153	Responsive Arthroscopy Suture Anchor System	Responsive Arthroscopy	MBI	Class II	2020-09-09
K201948	AcroDTI Visualizer	Acroviz, Inc.	LLZ	Class II	2020-09-09
K201829	SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)	MEDLINE INDUSTRIES, LP - Northfield	KGO	Class I	2020-09-09
K201578	DePuy Synthes Variable Angle Locking Patella Plating System	Synthes (USA) Products LLC	HRS	Class II	2020-09-09
K201551	KetoSens BT Blood B-Ketone Monitoring System	I-SENS, Inc.	JIN	Class I	2020-09-09
K201539	Keeogo Dermoskeleton System	B-Temia, Inc.	PHL	Class II	2020-09-09
K201252	Spectralis HRA+OCT and variants	Heidelberg Engineering GmbH	OBO	Class II	2020-09-09
K201090	Structur CAD	Voco GmbH	EBG	Class II	2020-09-09
K200851	Vivid T8, Vivid T9	GE Healthcare	IYN	Class II	2020-09-09
K200708	Vivid iq	GE Medical Systems Ultrasound and	IYN	Class II	2020-09-09
K200027	Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter	Jiangsu Caina Medical Co., Ltd	JKA	Class II	2020-09-09
K193664	SubQKath Catheter and Needle Set	HK Surgical Inc	BSO	Class II	2020-09-09
K193462	ClotTriever Thrombectomy System	Inari Medical, Inc.	QEW	Class II	2020-09-09
K193409	Vista Rinse, Vista Rinse Plus	Inter-Med/Vista Dental Products	KJJ	Unclassified	2020-09-09
K192822	Benesta Hysteroscope	Caldera Medical, Inc.	HIH	Class II	2020-09-09
K192730	Calcium-Cresolphthalein, Glucose, Urea/bun-UV	Biosystems S.A.	CHW	Class II	2020-09-09
K192653	Perseus	Orthokey Italia S.r.l.	OLO	Class II	2020-09-09
K192423	MINT Product Family	Hans Biomed Corp.	NEW	Class II	2020-09-09
K202354	Surgical Mask-Model Number CW01	Hunan Heng Chang Pharmaceutical Co., Ltd.	FXX	Class II	2020-09-08
K202328	CD Horizon Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2020-09-08
K202252	ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N),	Asahi Intecc Co., Ltd.	DQY	Class II	2020-09-08
K202014	Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit	Siemens Medical Solutions USA, Inc.	LNH	Class II	2020-09-08
K201470	Disposable Medical Face Mask	JKH USA, LLC	FXX	Class II	2020-09-08
K201194	Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens	Acuity Polymers Inc.	HQD	Class II	2020-09-08
K201841	EyeBOX	Oculogica Inc.	QEA	Class II	2020-09-06
K202335	Ambra ProViewer	Dicom Grid Inc dba Ambra Health	LLZ	Class II	2020-09-04
K202238	SIGNA Artist	GE Healthcare (Tianjin) Company Limited	LNH	Class II	2020-09-04
K202197	Astopad Patient Warming System	Stihler Electronic GmbH	DWJ	Class II	2020-09-04
K201721	TruLift Expandable Spacer System	Life Spine	MAX	Class II	2020-09-04
K201537	Protective Face Mask for Medical Use	Shandong Shengquan New Material Co., Ltd.	FXX	Class II	2020-09-04
K201517	Plain Surgical Mask	AOK Tooling Limited	FXX	Class II	2020-09-04