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 2026-10-19, 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 486 of 3529

510(k) clearances, page 486 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K182518	AHMED ClearPath Glaucoma Drainage Device	New World Medical, Inc.	KYF	Class II	2019-01-18
K182323	PICO 7Y Single Use Negative Pressure Wound Therapy System	Smith & Nephew Medical Ltd	OMP	Class II	2019-01-18
K182284	Tyber Medical PT Interbody Spacer	Tyber Medical	ODP	Class II	2019-01-18
K182211	Aurora Surgiscope System	Rebound Therapeutics, Corporation	GWG	Class II	2019-01-18
K181895	Kurin PIV Blood Collection Set with High Pressure	Kurin, Inc.	JKA	Class II	2019-01-18
K181126	Reprocessed Visions PV .035 Digital IVUS Catheter	Innovative Health, LLC.	OWQ	Class II	2019-01-18
K181099	Bright Guard	Koncept Innovators, LLC	OBR	Unclassified	2019-01-18
K181097	Cook Cystostomy Catheter Set	Cook Incorporated	KOB	Class II	2019-01-18
K181084	PENTAX Video Colonoscopes (EC Family)	PENTAX of America, Inc.	FDF	Class II	2019-01-18
K181076	Responsive Arthroscopy Wedge Push-In Suture Anchors	Responsive Arthroscopy	MBI	Class II	2019-01-18
K180236	VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)	VR Medical Technology Co., Ltd.	FPD	Class II	2019-01-18
K183538	VIVA combo RF System	Starmed Co.,Ltd	GEI	Class II	2019-01-17
K183060	CervAlign™ Anterior Cervical Plate System	Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.)	KWQ	Class II	2019-01-17
K182456	Study Watch	Verily Life Sciences, LLC	DXH	Class II	2019-01-17
K182227	Esprit Nova	Neurozone Msh Incorporated	OLZ	Class II	2019-01-17
K182111	DL Self-adhesive Electrode	Shaoxing DL Healthcare Co., Ltd.	GXY	Class II	2019-01-17
K182010	ProgenaMatrix	Cell Constructs I, LLC	KGN	Unclassified	2019-01-17
K181338	Imboki Knee Instrument System	Signature Orthopaedics Pty Limited	JWH	Class II	2019-01-17
K181302	Bodycad Unicompartmental Knee System	Bodycad Laboratories, Inc.	HSX	Class II	2019-01-17
K181190	Pinehurst Anterior Cervical Plate System	Signature Orthopaedics Pty Limited	KWQ	Class II	2019-01-17
K180779	Savina 300	Drägerwerk AG & Co. KGaA	CBK	Class II	2019-01-17
K183510	T2 STRATOSPHERE Expandable Corpectomy System	Medtronic Sofamor Danek USA Inc	MQP	Class II	2019-01-16
K183474	Carestream DRX-1 System with DRX Core Detectors	Eastman Kodak Company	MQB	Class II	2019-01-16
K183329	Laser Hair Therapy	Omm Imports, Inc. D/B/a Zero Gravity	OAP	Class II	2019-01-16
K183165	Pristine Scope	Pristine Surgical LLC	HRX	Class II	2019-01-16
K182651	HbA1c Advanced	Beckman Coulter Ireland Inc	PDJ	Class II	2019-01-16
K182538	Merit RadialFlo Arterial Catheter	Merit Medical Singapore Pte. Ltd.	FOZ	Class II	2019-01-16
K182489	4CIS® Pinehurst Anterior Cervical Plate system	Solco Biomedical Corp.	KWQ	Class II	2019-01-16
K181540	Estremo Citieffe Nailing System	Citieffe Inc.	HSB	Class II	2019-01-16
K181451	Uretero-Reno Videoscope Olympus Urf-V3/v3r, Uretero-Reno Fiberscope Olympus Urf-P7/p7r	Olympus Medical Systems Corp.	FGB	Class II	2019-01-16
K181106	Powder Free Nitrile Patient Examination Gloves, Blue Color	Jiangsu Dongxin Medical Technology Co., Ltd.	LZA	Class I	2019-01-16
K181071	SIRA RFA Electrosurgical Device	Innoblative Designs, Inc.	GEI	Class II	2019-01-16
K180410	Dosis SAM	Dosis, Inc.	MQS	Class II	2019-01-16
K173847	Disposable Ultra Reinforced Surgical Gown	Xiantao Rayxin Medical Products Co., Ltd.	FYA	Class II	2019-01-16
K183497	JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor	Nanjing Jusha Display Technology Co., Ltd	PGY	Class II	2019-01-15
K182497	OsteoCool RF Ablation System	Medtronic Sofamor Danek USA Inc	GEI	Class II	2019-01-15
K182478	Whistler Modular Pedicle Screw System	Evolution Spine, LLC	NKB	Class II	2019-01-15
K181096	Avenue P Cage System	Highridge Medical, LLC	OVD	Class II	2019-01-15
K183514	ZELTIQ CoolSculpting System	Zeltiq Aesthetics Inc	OOK	Class II	2019-01-14
K182898	TenoTac Soft Tissue Fixation System	Paragon 28	MBI	Class II	2019-01-14
K182307	Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System	Paragon 28	HSB	Class II	2019-01-14
K180570	Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)	Argentum Medical, LLC	FRO	Unclassified	2019-01-14
K183467	Roadrunner Extra Support Wire Guide	Cook Incorporated	DQX	Class II	2019-01-11
K183406	CereLink ICP Monitor, CereLink ICP Extension Cable	Integra LifeSciences Corporation	GWM	Class II	2019-01-11
K183140	MTS Tetracycline 0.016 - 256 ug/mL	Liofilchem S.r.l.	JWY	Class II	2019-01-11
K183137	uMR 580, uMR 588	Shanghai United Imaging Healthcare Co., Ltd.	LNH	Class II	2019-01-11
K183031	ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)	bioMerieux, Inc.	JWY	Class II	2019-01-11
K182973	DigitalDiagnost C90	Philips Medical Systems DMC GmbH	MQB	Class II	2019-01-11
K182928	CD Horizon™ Spinal System	Medtronic Sofamor Danek USA Inc	NQP	Class II	2019-01-11
K182545	Tamper Evident Cap with Male Luer Lock	Intl. Medical Industries	FPA	Class II	2019-01-11