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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1254 of 3531

510(k) clearances, page 1254 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K061065	Fecal Occult Blood Card Test, Model F735-a, Fecal Occult Blood Card Kit, Model F735-25	Teco Diagnostics	KHE	Class II	2006-07-14
K061050	Gynecare Morcellex Tissue Morcellator, Models Mx0100 and Mx0100r	Ethicon, Inc	HET	Class II	2006-07-14
K061037	Pds Plus Antibacterial Suture	Ethicon, Inc	NEW	Class II	2006-07-14
K060952	Collagen Nerve Wrap	Collagen Matrix, Inc	JXI	Class II	2006-07-14
K060812	Powerport(tm)implanted Titanium Port W/8 Fr. Chronoflex Catheter-Multiple	C.R. Bard Inc	LJT	Class II	2006-07-14
K060067	Maskmedic Concept Nasal Mask	Maskmedic	BZD	Class II	2006-07-14
K053656	Tyrx Antimicrobial Mesh	Tyrx Pharma, Inc.	FTL	Class II	2006-07-14
K053646	Invitro Maturation Media	Sage In-Vitro Fertilization, Inc.	MQL	Class II	2006-07-14
K053578	Scorpion Ultrasonic Scaling Inserts	Scorpion	ELC	Class II	2006-07-14
K061751	Dimension Vista System Ucfp Calibrator, Model Kc260	Siemens Healthcare Diagnostics Inc.	JIT	Class II	2006-07-13
K061514	Bruno Vertical Platform Lift, Model Vpl-3100	Bruno Independent Living Aids, Inc.	ING	Class II	2006-07-13
K060467	Prodigy Blood Glucose Test System	Diagnostic Devices, Inc.	NBW	Class II	2006-07-13
K060384	Coramate/spirotome System	Medinvents	KNW	Class II	2006-07-13
K061859	Inovel Health Care N95 Particulate Respirators & Surgical Masks	Moldex/Metric, Inc.	MSH	Class II	2006-07-12
K061817	Lightspeed 7.1 CT Scanner System	GE Healthcare	JAK	Class II	2006-07-12
K061816	Galaxy	Larsen & Toubro Limited	MWI	Class II	2006-07-12
K061732	Tap-T	Airway Management Inc.	LRK	Class II	2006-07-12
K061698	Modification to Life Spine Cement Restrictor	Life Spine	JDK	Class II	2006-07-12
K061682	Ge Voluson E8 Ultrasound System	General Electric Co.	IYO	Class II	2006-07-12
K061619	Inspectra Sto2 Tissue Oxygenation Monitor	Hutchinson Technology, Inc.	MUD	Class II	2006-07-12
K061593	Atricure Isolator Transpolar Pen System, Models Asu2, Max1, Max2 and Asb1	AtriCure, Inc.	OCL	Class II	2006-07-12
K061452	Tf-Bp01 Blood Pressure Measurement System	Tung FU Electric Co., Ltd.	DXN	Class II	2006-07-12
K061365	Checkpoint with Accustim Technology	Ndi Medical, LLC	ETN	Class II	2006-07-12
K061363	Agilis Nxt Steerable Introducer	Abbott Medical	DYB	Class II	2006-07-12
K061058	Neozoline Ventilation Tubes	Adept Medical Ltd	ETD	Class II	2006-07-12
K061044	Featherlite Aqua Tocodynamometer	Ventrex, Inc.	HFM	Class II	2006-07-12
K060643	Ql Locking Syringe	Atrion Medical Products, Inc.	MAV	Class II	2006-07-12
K060425	Parallax Acrylic Resin Cartridge with Tracers-Ta	ArthroCare Corporation	NDN	Class II	2006-07-12
K060232	Trokamed Gmbh Electrosurgical Instruments & Accessories	Trokamed GmbH	GEI	Class II	2006-07-12
K060191	Acp Omnipad Light Therapy System & Acp Omnipad 500 Control Unit	Accelerated Care Plus Corp.	ILY	Class II	2006-07-12
K053623	Nfix Fusion System	N Spine, Inc.	MNH	Class II	2006-07-12
K053584	Iplan Rt Dose	Brainlab, Inc.	MUJ	Class II	2006-07-12
K053246	Patient Matched Hip Stem	Smith & Nephew, Inc.	LZO	Class II	2006-07-12
K051688	For Play, Slip, Prepair - Personal Lubricants	Trimensa Pharmaceuticals	NUC	Class II	2006-07-12
K061791	Focus Vng/eng Type 1068	Natus Medical Denmark ApS	GWN	Class II	2006-07-11
K061788	Boehringer Laboratories Suction Pump System	Boehringer Laboratories, LLC	OMP	Class II	2006-07-11
K061772	Triactiv Fx Embolic Protection System	DSM Biomedical, Inc.	NFA	Class II	2006-07-11
K061562	Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color	Grand Work Plastic Products Co., Ltd.	LYZ	Class I	2006-07-11
K061398	Snug Plug Punctum Plug	Fci Ophthalmics, Inc.	LZU	Unclassified	2006-07-11
K061135	Minop Disposable Introducer 10F, Model Me010; 19F, Model Me019	Aesculap Inc	GWG	Class II	2006-07-11
K061133	Simex Suction Pump, Models Ac20, Ac20k, Ac30, Dc20, Dc30 and Dc30s	Novaspine, LLC	BTA	Class II	2006-07-11
K061011	Competitor Unicondylar Knee Tibial Baseplate	Smith & Nephew, Inc.	HSX	Class II	2006-07-11
K060986	Head Bed	Steven H. Warnock, M.D.	FRP	Class I	2006-07-11
K060497	Babyair	Promedic, Inc.	CAF	Class II	2006-07-11
K061771	Ez-Connect	Teleflex Medical	FPA	Class II	2006-07-10
K061702	Dimension Vista System Creatine Kinase Calibrator (Ck Cal - Kc340)	Siemens Healthcare Diagnostics Inc.	JIT	Class II	2006-07-10
K061677	Solar Purefix Ha Shoulder	Howmedica Osteonics Corp	HSD	Class II	2006-07-10
K061667	Cell-Dyn Ruby System	Abbott Medical	GKZ	Class II	2006-07-10
K061655	Dimension Vista Flex Reagent Cartridges	Siemens Healthcare Diagnostics Inc.	LDP	Class II	2006-07-10
K061511	R&d Cbc-3D + Crp Hematology Control	R & D Systems, Inc.	JPK	Class II	2006-07-10