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 484 of 3529

510(k) clearances, page 484 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K183291	Supria True64 Whole-Body X-Ray CT System	FUJIFILM Healthcare Americas Corporation	JAK	Class II	2019-02-01
K183275	DR 800 with Tomosynthesis	Agfa N.V.	IZF	Class II	2019-02-01
K183272	AI Rad Companion (Engine)	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2019-02-01
K183139	Endoscope Sterilization Tray	Intuitive Surgical, Inc.	KCT	Class II	2019-02-01
K182744	HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High	Eurotrol B.V.	GGM	Class II	2019-02-01
K182319	Glo-Tip Spray Catheter	Wilson-Cook Medical Inc.	OCX	Class II	2019-02-01
K182191	Invia Abdominal Dressing Kit	Medela AG	OMP	Class II	2019-02-01
K182094	Family of Venus RF Systems - Heal	Venus Concept USA Inc.	PBX	Class II	2019-02-01
K181751	HemoCue Hb 801 System	HemoCue AB	GKR	Class II	2019-02-01
K181657	easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use	Ezisurg Medical Co., Ltd.	GDW	Class II	2019-02-01
K181070	iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)	Andon Health Co., Ltd	NBW	Class II	2019-02-01
K180626	Pedimax II - Pedicular Screw Spinal System	Gm dos Reis Industria E Comerico Ltda.	NKB	Class II	2019-02-01
K183020	Endosee System	CooperSurgical, Inc.	HIH	Class II	2019-01-31
K182827	SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900	STERIS Corporation	MED	Class II	2019-01-31
K182198	Panoura X-ERA PF/NF/MF	The Yoshida Dental Mfg. Co., Ltd.	MUH	Class II	2019-01-31
K181129	STRONG Dental Handpieces	Saeshin Precision Co., Ltd.	EGS	Class I	2019-01-31
K183696	Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid	TORNIER Inc.	PHX	Class II	2019-01-30
K183136	Zimmer Segmental System Proximal Femoral Component	Zimmer GmbH	LZO	Class II	2019-01-30
K183029	MOTO Partial Knee System	Medacta International SA	HSX	Class II	2019-01-30
K182986	Boston Keratoprosthesis, Type I Lucia	Massachusetts Eye and Ear Infirmary D/B/A Boston	HQM	Class II	2019-01-30
K182327	Patient Cables and Leadwires , Disposable ECG Leadwires	Orantech Inc.	DSA	Class II	2019-01-30
K183070	ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010	Asahi Intecc Co., Ltd.	MOF	Class II	2019-01-29
K183022	Solitaire 4 Revascularization Device	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	POL	Class II	2019-01-29
K182648	X5 Series Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	IYN	Class II	2019-01-29
K182521	FastPack IP Sex Hormone Binding Globulin Immunoassay	Qualigen Inc	CDZ	Class I	2019-01-29
K182000	AQrate Robotic Assistance System	Globus Medical, Inc.	HAW	Class II	2019-01-29
K181893	T-Plus	Wintecare SA	PBX	Class II	2019-01-29
K181580	Cortex CAD/CAM Abutments	Cortex Dental Implants Industries Ltd.	NHA	Class II	2019-01-29
K181048	Neo Cage System TM	Neo Medical, Inc.	MAX	Class II	2019-01-29
K183456	Aloka Arietta 850	FUJIFILM Healthcare Americas Corporation	IYN	Class II	2019-01-28
K183362	Venue GO	GE Healthcare	IYN	Class II	2019-01-28
K183025	MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component	b-ONE Ortho Corp.	JWH	Class II	2019-01-28
K183004	Wego-Pga Rapid	Foosin Medical Supplies Inc., Ltd.	GAM	Class II	2019-01-28
K183001	Wego-Pgla Rapid	Foosin Medical Supplies Inc., Ltd.	GAM	Class II	2019-01-28
K182477	Cervical Spacer	Additive Implants	ODP	Class II	2019-01-28
K182228	MIS LOCKiT Abutments System, OT-Equators and Ball Attachments	MIS Implants Technologies Ltd.	NHA	Class II	2019-01-28
K182093	ZOLL ECG Analysis Software	ZOLL Manufacturing Corporation	DPS	Class II	2019-01-28
K181775	Quantum Blood and IV Fluid Infusion Warmer	Life Warmer, Inc.	LGZ	Class II	2019-01-28
K181307	Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow	Zimmer GmbH	JDC	Class II	2019-01-28
K180822	VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System	Wenzel Spine	MAX	Class II	2019-01-28
K173743	Greenmedi Safety Filter Syringe	Sang-A Frontec Co., Ltd.	MEG	Class II	2019-01-28
K183631	medi pneumatic compression system (pcs) – brio (Model 651)	Medi USA, LP	JOW	Class II	2019-01-25
K183615	Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle	Avenu Medical, Inc.	PQK	Class II	2019-01-25
K183468	Revive Reusable Bladder Support	Rinovum Subsidiary 2, LLC	HHW	Class II	2019-01-25
K183321	Treace Medical Concepts (TMC) Plating System	Treace Medical Concepts, Inc.	HRS	Class II	2019-01-25
K183228	HammerToe Compression System	Paragon 28	HTY	Class II	2019-01-25
K183042	SMR Lateralized Connectors with screws	Lima Corporate S.p.A.	KWS	Class II	2019-01-25
K182968	Hoffmann LRF System	Stryker Corp.	KTT	Class II	2019-01-25
K182919	SI-Restore® Sacroiliac Joint Fixation System	Biofusion Medical	OUR	Class II	2019-01-25
K182895	Wilson-Cook Achalasia Balloon	Wilson-Cook Medical Inc.	PID	Class II	2019-01-25