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 422 of 3528

510(k) clearances, page 422 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K190641	AR_N SLA Type Implant System	Biotem Co., Ltd.	DZE	Class II	2020-02-21
K190363	Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage	Omnia Medical	MAX	Class II	2020-02-21
DEN190023	AmplideX Fragile X Dx & Carrier Screen Kit	Asuragen, Inc.	OYV	Class II	2020-02-21
K193596	Wingman 14, Wingman 14C, Wingman 18, Wingman 35	ReFlow Medical, Inc	DQY	Class II	2020-02-20
K193533	WIN Flexible Nail System	Zimmer GmbH	JDS	Class II	2020-02-20
K193303	Tinnitus Sound Generator Module	GN Hearing A/S	KLW	Class II	2020-02-20
K193255	Largo PEEK Interbody System	Flospine LLC	MAX	Class II	2020-02-20
K193098	Exactech® Equinoxe® Reverse Shoulder Glenospheres	Exactech, Inc.	PHX	Class II	2020-02-20
K193015	HydroPICC (PICC-142)	Access Vascular, Inc	LJS	Class II	2020-02-20
K192922	Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter	Gentuity, LLC	NQQ	Class II	2020-02-20
K192918	Video Laparoscope, Video Processor, Light Source	FUJIFILM Corporation	GCJ	Class II	2020-02-20
K192624	ApneaTrak	Cadwell Industries Inc	OLV	Class II	2020-02-20
K192617	Gemini 810+980 Soft Tissue Laser	Azena Medical	GEX	Class II	2020-02-20
K192545	Potenza	Jeisys Medical Incorporated	GEI	Class II	2020-02-20
K191719	X-MIND Trium	De Gotzen S.r.l.	MUH	Class II	2020-02-20
K190806	Flowart	Asset Medikal Tasarim AS.	FPA	Class II	2020-02-20
K190406	SDS2.2 dental implant	SDS Swiss Dental Solutions	DZE	Class II	2020-02-20
K200228	ClearCam System	Clearcam	GCJ	Class II	2020-02-19
K193209	Wego-Stainless Steel	Foosin Medical Supplies Inc., Ltd.	GAQ	Class II	2020-02-19
K193012	speX Support Catheter	ReFlow Medical, Inc	DQY	Class II	2020-02-19
K192973	densitas densityai	Densitas Inc.	LLZ	Class II	2020-02-19
K192460	Sentinel Cerebral Protection System	Boston Scientific Corporation	PUM	Class II	2020-02-19
K192000	D R Burton OxyPAP	D R Burton Healthcare, LLC	BWF	Class II	2020-02-19
K200179	Collaboration Live	Philips Health Care	LLZ	Class II	2020-02-18
K200132	Ashvins	Medicalcommunications GmbH	LLZ	Class II	2020-02-18
K193203	MOJAVE Expandable Interbody System	K2M, Inc	MAX	Class II	2020-02-18
K192894	Vita Flex CR System with LLI	Eastman Kodak Company	MQB	Class II	2020-02-18
K192674	Mixing and Delivery System	Bone Solutions, Inc.	FMF	Class II	2020-02-18
K192381	DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor	Scientific Pharmaceuticals, Inc.	LBH	Class II	2020-02-18
K191514	CareStart Flu A&B Plus	Access Bio, Inc.	PSZ	Class II	2020-02-18
K190487	InPen Dose Calculator	Companion Medical, Inc.	NDC	Class II	2020-02-18
K193554	APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System	Medartis AG	HRS	Class II	2020-02-16
K193466	Swan-Ganz Catheters	Edwards Lifesciences LLC	DYG	Class II	2020-02-16
K200083	EMBA Hourglass Peripheral Embolization Device (PED)	Embolic Acceleration, LLC	KRD	Class II	2020-02-14
K193644	E-Com Dr-2000 Dr	Livermoretech,Inc	MQB	Class II	2020-02-14
K193567	VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)	bioMerieux, Inc.	LON	Class II	2020-02-14
K193502	TGS Universal Headrest with Mounting Arm	Stryker Ent	PGW	Class II	2020-02-14
K193475	OneTouch Verio Reflect Blood Glucose Monitoring System	Lifescan Europe GmbH	NBW	Class II	2020-02-14
K193248	Biograph Vision, Biograph mCT Family of PET/CTs	Siemens Medical Solutions USA, Inc.	KPS	Class II	2020-02-14
K193245	Dunamis PunchTac Suture Anchors	Dunamis, LLC	MBI	Class II	2020-02-14
K193152	Affinity	Hermes Medical Solutions AB	KPS	Class II	2020-02-14
K193120	Real Intelligence Cori	Blue Belt Technologies, Inc.	OLO	Class II	2020-02-14
K192923	Vitrea Software Package	Canon Medical Systems Corporation	LLZ	Class II	2020-02-14
K192662	CapsoCam Plus (SV-3) Capsule Endoscopy System	CapsoVision, Inc.	NEZ	Class II	2020-02-14
K192372	ASCEND Image Viewer	Ascend Hit	LLZ	Class II	2020-02-14
K192277	CardIQ Flow	GE Medical Systems SCS	KPS	Class II	2020-02-14
K192143	Maximus System	Hill-Rom Services Pte, Ltd.	NHJ	Class II	2020-02-14
K192120	Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm	Venner Medical (Singapore) Pte Ltd	BTR	Class II	2020-02-14
K191785	Orion LifeSpan MEG	Compumedics Limited	OLY	Class II	2020-02-14
K191737	The Graft Bone Substitute	Purgo Biologics Inc.	NPM	Class II	2020-02-14