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 421 of 3528

510(k) clearances, page 421 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K191946	Penumbra System Penumbra JET 7X	Penumbra Inc.	NRY	Class II	2020-02-27
K191462	Proov Test	MFB Fertility, Inc.	QKE	Class I	2020-02-27
K190919	ST Internal Implant System	T-Plus Implant Tech. Co., Ltd.	DZE	Class II	2020-02-27
K190682	Explorer Mini	Permobil, AB	IPL	Class II	2020-02-27
K190032	Disposable Sclerotherapy Needle	Hangzhou AGS MedTech Co., Ltd.	FBK	Class II	2020-02-27
K200197	ARK Fentanyl II Assay	Ark Diagnostics Inc	DJG	Class II	2020-02-26
K200189	Luna Dental Implant System- Healing Abutment	Shinhung MST Co., Ltd.	NHA	Class II	2020-02-26
K193506	NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System	Nu Vasive, Incorporated	MQP	Class II	2020-02-26
K192192	VSP System	3D Systems, Inc.	DZJ	Class II	2020-02-26
K191463	DePuy Synthes Hammertoe Continuous Compression Implant	Synthes (USA) Products LLC	JDR	Class II	2020-02-26
K200236	VITROS BRAHMS PCT Reagent Pack and Calibrators	Ortho-Clinical Diagnostics, Inc.	PMT	Class II	2020-02-25
K200234	Surgical laser fibers	Quanta System Inc.	GEX	Class II	2020-02-25
K200178	Ez3D-i /E3	Ewoosoft Co., Ltd	LLZ	Class II	2020-02-25
K200016	uCT 530, uCT 550	Shanghai United Imaging Healthcare Co., Ltd.	JAK	Class II	2020-02-25
K193414	Trigon HA Stand-Alone Wedge Fixation System	Nvision Biomedical Technologies, Inc	PLF	Class II	2020-02-25
K192898	PneumoLiner	Advanced Surgical Concepts	PMU	Class II	2020-02-25
K192253	SonicEye Dual-Array Ultrasound System	Sonivate Medical, Inc.	IYO	Class II	2020-02-25
K191402	Heater-Cooler System 3T	LivaNova Deutschland GmbH	DWC	Class II	2020-02-25
K191389	Allcem Veneer APS	Dentscare Ltda	EBF	Class II	2020-02-25
DEN190020	iTind System	Medi-Tate	QKA	Class II	2020-02-25
K200214	3D Predict	3D Smile USA, Inc.	NXC	Class II	2020-02-24
K193451	Titanium Interference Screws	Zimmer GmbH	HWC	Class II	2020-02-24
K193412	NEXXT MATRIXX System	Nexxt Spine LLC	PLR	Class II	2020-02-24
K193180	Alliance Augmented Glenoid	Zimmer GmbH	KWS	Class II	2020-02-24
K192855	DELTA XTEND(TM) Reverse Shoulder System	Depuy (Ireland)	PHX	Class II	2020-02-24
K192756	Aquadex FlexFlow System 2.0	Chf Solutions, Inc.	KDI	Class II	2020-02-24
K191858	Pylant Monitor	Kal-Med, LLC.	BSK	Class II	2020-02-24
K191474	NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)	Fresenius Medical Care Renal Therapies Group, LLC	KPO	Class II	2020-02-24
K193308	T2 Alpha Tibia Nailing System, IMN Screws System	Stryker Trauma GmbH	HSB	Class II	2020-02-23
K200184	SmoothSkin Pure	Cyden Limited	OHT	Class II	2020-02-21
K200161	3MP Monochrome Digital Mammography LCD Monitor MS-S300	JVCKENWOOD Corporation	PGY	Class II	2020-02-21
K200148	LightForce Orthodontic System (LFO System)	LightForce Orthodontics	NJM	Class II	2020-02-21
K193118	TGS Guidewire and updated Scopis Software	Stryker Ent	PGW	Class II	2020-02-21
K192851	OASIS MRI System	FUJIFILM Healthcare Americas Corporation	LNH	Class II	2020-02-21
K192832	Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i	Canon Medical Systems Corporation	JAK	Class II	2020-02-21
K192799	Glenoid Baseplate with Screw	Fx Shoulder USA, Inc.	PHX	Class II	2020-02-21
K192691	PatCom Single-Use Introducer	H&A Mui Enterprises, Inc.	FED	Class II	2020-02-21
K192600	Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60	Quanta System Inc.	GEX	Class II	2020-02-21
K192491	Coolief Radiofrequency Generator (CRG) System	Halyard Health	GXD	Class II	2020-02-21
K192263	UCLA CCM Abutment	Dio Corporation	NHA	Class II	2020-02-21
K192072	Tina-quant C-Reactive Protein IV	Roche Diagnostics Operations (Rdo)	DCN	Class II	2020-02-21
K191894	Upper Arm Blood Pressure Monitor	Shenzhen Zhengkang Technology Co., Ltd.	DXN	Class II	2020-02-21
K191740	DORO LUCENT® iXI and iMRI Headrest System	Black Forest Medical GmbH	HBL	Class II	2020-02-21
K191728	ULTepap Expiratory Positive Airway Pressure (EPAP) Device	Bryggs Medical, LLC	OHP	Class II	2020-02-21
K191697	Cardiac Monitor 1500	Altivera Medical, Inc.	DSB	Class II	2020-02-21
K191646	Beamscan MR	Ptw-Freiburg Physikalisch-Technische-Werkstaetten	IYE	Class II	2020-02-21
K191536	Biatain Silicone Ag	MEDLINE INDUSTRIES, LP - Northfield	FRO	Unclassified	2020-02-21
K191407	Novalung System	Fresenius Medical Care Renal Therapies Group, LLC	QJZ	Class II	2020-02-21
K191313	Unity Subcutaneous Infusion System for Remodulin	Deka Research & Development Corp.	QJY	Class II	2020-02-21
K191030	Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer	Life Technologies Corporation	PCA	Class II	2020-02-21