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 335 of 3528

510(k) clearances, page 335 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K211708	Disposable Medical Nitrile Gloves	Jiangsu Health-Peace Medical Technology Co., Ltd.	LZA	Class I	2021-08-17
K211671	Journey II Mid-Level Tibial Inserts	Smith & Nephew, Inc.	JWH	Class II	2021-08-17
K211376	STARband	Orthomerica Products, Inc.	OAN	Class II	2021-08-17
K210998	ROSA Hip System	Orthosoft D/B/A Zimmer Cas	LLZ	Class II	2021-08-17
K210201	Deep Transcranial Magnetic Stimulation (DTMS) System	Brainsway Ltd.	OBP	Class II	2021-08-17
K203820	ASPIVIX v1.1 Cervical Suction Tenaculum	Aspivix SA	HDC	Class II	2021-08-17
K203089	Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System	Dexcom, Inc.	QDK	Class II	2021-08-17
K201573	Brain Perfusion (BP) application	Philips Medical Systems Nederland B.V.	LLZ	Class II	2021-08-17
K212230	TruSPECT Radiological Image Processing Station	Spectrum Dynamics Medical Inc.	LLZ	Class II	2021-08-16
K212066	Adena-Zina System	Shanghai Sanyou Medical Co. Ltd	NKB	Class II	2021-08-16
K211703	Insignia Hip Stem	Stryker Orthopaedics	MEH	Class II	2021-08-16
K211654	Penumbra System (Reperfusion Catheter RED 72)	Penumbra Inc.	NRY	Class II	2021-08-16
K211294	Multi-Link X2 ECG Cable and Leadwire System	Jaeger Medical GmbH	DSA	Class II	2021-08-16
K210841	NuVent Eustachian Tube Dilation Balloon	Medtronic Xomed, Inc.	PNZ	Class II	2021-08-16
K210695	CPM Medical Consultants Tibial Revision Knee System	CPM Medical Consultants, LLC.	JWH	Class II	2021-08-16
K210569	Disposable Monopolar Laparoscopic Shafts and Reusable Handles	Dannik	GEI	Class II	2021-08-16
K203236	Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove	Rhino Health, Inc.	LZA	Class I	2021-08-16
K202636	Metallic Fabric Electrodes	Guangzhou Xinbo Electronic Co., Ltd	GXY	Class II	2021-08-16
K201094	iMap 3D Mapping & Navigation System (iMap System)	Cardionxt	DQK	Class II	2021-08-16
K210381	I.V. Administration Set	BQ Plus Medical Co., Ltd.	FPA	Class II	2021-08-14
K212229	White Endoseal MTA	Maruchi	KIF	Class II	2021-08-13
K212228	WATCHMAN FXD Curve Access System	Boston Scientific Corporation	DQY	Class II	2021-08-13
K212206	Jot Dx Insertable Cardiac Monitor	Abbott (St. Jude Medical)	MXC	Class II	2021-08-13
K211969	EMM Ultrasonic Transducer Cover	Exact Medical Manufacturing, Inc.	ITX	Class II	2021-08-13
K211860	Powder Free Nitrile Patient Examination Gloves, Blue Color	Anhui Powerguard Technology Co., Ltd.	LZA	Class I	2021-08-13
K211777	Arco Fp-S	A.T.S. Applicazione Tecnologie Speciali S.r.l.	OWB	Class II	2021-08-13
K211588	Caretaker Platform, VitalStream Platform, CT5	Caretaker Medical	DXN	Class II	2021-08-13
K211575	Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System	Insulet Corporation	LZG	Class II	2021-08-13
K211563	Pitch-Patchs	Xiros Ltd	FTL	Class II	2021-08-13
K211519	Every Cycle Reusable Tampon Applicator	Cycle, LLC	HEB	Class II	2021-08-13
K211383	NFLK-2501 Portable X-ray Unit	Neuf, Inc.	IZL	Class II	2021-08-13
K210958	i-STAT CHEM8+ cartridge with the i-STAT 1 System	Abbott Medical	CGA	Class II	2021-08-13
K210858	VITROS Chemistry Products PHBR Slides	Ortho-Clinical Diagnostics, Inc.	DLZ	Class II	2021-08-13
K210671	Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107	Weony (Shenzhen) Technology Co., Ltd.	DXN	Class II	2021-08-13
K210336	Neodent Implant System - Zirconia Implant System	JJGC Industria e Comercio de Materiais Dentarios SA	DZE	Class II	2021-08-13
K203817	Tyber Medical Anatomical Plating System	Tyber Medical	HRS	Class II	2021-08-13
K203693	Nisus Touch Negative Pressure Wound Therapy Pump	Cork Medical Products, LLC	OMP	Class II	2021-08-13
K202279	Insignis Subcutaneous Needle Sets	Innovative Health Sciences	FPA	Class II	2021-08-13
K200913	Clearblue® Early Digital Pregnancy Test	SPD Swiss Precision Diagnostics GmbH	LCX	Class II	2021-08-13
K192823	Mega-Tms	Soterix Medical,Inc.	GWF	Class II	2021-08-13
K212007	VERTICALE Navigation Instruments	Silony Medical GmbH	OLO	Class II	2021-08-12
K211863	eVolve PACS	Evolve Pacs, Inc.	LLZ	Class II	2021-08-12
K211205	Prase-C Anterior Cervical Plate System	Gbs Commonwealth Co., Ltd.	KWQ	Class II	2021-08-12
K211179	InferRead CT Stroke.AI	Infervision Medical Technology Co., Ltd.	QAS	Class II	2021-08-12
K210946	Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles	Promisemed Hangzhou Meditech Co.,Ltd.	KNW	Class II	2021-08-12
K210912	Excelsius3D	Globus Medical, Inc.	OWB	Class II	2021-08-12
K210661	SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset	Quanta Dialysis Technologies Ltd	KDI	Class II	2021-08-12
K210510	Disposable Surgical Gown	Shandong Zhushi Pharmaceutical Group Co., Ltd	FYA	Class II	2021-08-12
K210327	First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup	WHPM Inc.	QBF	Class II	2021-08-12
K203363	Crosser iQ CTO Recanalization System	C.R. Bard Inc	PDU	Class II	2021-08-12