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 1418 of 3531

510(k) clearances, page 1418 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K031995	Comprehensive Neuromuscular Profiler	Medical Technologies Unlimited, Inc.	IKN	Class II	2004-01-07
K031936	Osteomed Orthodontic Screw System	Osteomed	DZE	Class II	2004-01-07
K033659	Varian, Inc. Ontrak Testcup and Ontrak Teststik	Varian, Inc.	DKZ	Class II	2004-01-06
K033514	Coda Cx1 Motion Analysis System	Charnwood Dynamics, Ltd.	LXJ	Class II	2004-01-06
K033834	Omnilink .018 Biliary Stent System	Boston Scientific Corporation	FGE	Class II	2004-01-02
K033775	Hemosil Liquid Antithrombin Xl	Instrumentation Laboratory Co.	JBQ	Class II	2004-01-02
K033433	Nova Glucose Control Solutions	Nova Biomedical Corporation	JJX	Class I	2004-01-02
K033804	Bioanchor with Disposable Driver	Linvatec Corporation	HWC	Class II	2003-12-31
K033671	Gore Bioabsorbable Mesh	W. L. Gore & Associates, Inc.	OWT	Class II	2003-12-31
K033636	Ams Large Pore Polypropylene Mesh	American Medical Systems, Inc.	OTP	Class III	2003-12-31
K033242	Knee Interpositional Mini-Repair System (Kimrs)	Imaging Therapeutics, Inc.	HSH	Class II	2003-12-31
K032554	Gen-Probe Aptima Combo 2 Assay	Hologic, Inc.	LSL	Class II	2003-12-31
K033916	Gri-Bag, Gri-Bag Ap	Laboratorios Grifols, S.A.	KPE	Class II	2003-12-30
K033874	Myolight	GE Medical Systems F.I. Haifa	KPS	Class II	2003-12-30
K033836	Hydrocoil Embolic System (Hes)	Terumo Cardiovascular Systems Corporation	HCG	Class II	2003-12-30
K033794	Ulticare Disposable Syringe 3 Ml/cc	Ultimed, Inc.	FMF	Class II	2003-12-30
K033781	Bebig Isoseed I-125	Bebig Isotopen-Und Medizintechnik GmbH	KXK	Class II	2003-12-30
K033778	Modification to Bard Aquaguide Ureteral Conduit	C.R. Bard Inc	FED	Class II	2003-12-30
K033754	Tracer Metro Smart Wire Guide	Wilson-Cook Medical Inc.	OCY	Class II	2003-12-30
K033665	Venus Flow	Kulzer GmbH	EBF	Class II	2003-12-30
K033412	Mediclung, Release 1	Medicsight	OEB	Class II	2003-12-30
K033356	Verasoft Es	Aalba Dent, Inc.	EJH	Class II	2003-12-30
K033339	Acuity with Conebeam Computed Tomography	Varian Medical Systems, Inc.	KPQ	Class II	2003-12-30
K033317	Smartstitch M-Connector, Model Om-8700; Needle Cassette, Om-8750; Autocuff System Instrument Set, Om-9070	Opus Medical, Inc.	OCW	Class II	2003-12-30
K033256	Athena Pelvic Muscle Trainer II	Athena Feminine Technologies, Inc.	KPI	Class II	2003-12-30
K033250	Edwards Lifesciences Vantex Central Venous Catheters with Thermistor	Edwards Lifesciences LLC	FOZ	Class II	2003-12-30
K033147	Cleartooth Digital X-Ray System	Cleartooth Electronics, Inc.	MUH	Class II	2003-12-30
K032127	Hemedex Fixation Device	Hemedex Incorporated	KNY	Class II	2003-12-30
K033829	Bruno Electra-Ride III Stairway Elevator System, Model Cre-2100	Bruno Independent Living Aids, Inc.	ILK	Class II	2003-12-29
K033478	Vacuette Quickshield Safety Tube Holder	Greiner Bio-One Vacuette North America	FMI	Class II	2003-12-29
K033038	Gi Monitor and Gi Monitor Calibrators on the Access Immunoassay Systems, Model 387687, 387688	Siemens Healthcare Diagnostics Inc.	NIG	Class II	2003-12-29
K033906	Portascan Bladder Scanner, Model Pa00146	Mediwatch PLC	IYO	Class II	2003-12-24
K033487	Stratus Cs Acute Care Troponin I Testpak, Model Cctni	Siemens Healthcare Diagnostics Inc.	MMI	Class II	2003-12-24
K033371	Varian Intracavitary Brachytherapy Applicators	Varian Medical Systems, Inc.	JAQ	Class II	2003-12-24
K033001	Apex Detector Electronics & Acquisition Interface, Model Xl-4	Transphoton Corporation	KPS	Class II	2003-12-24
K032571	Immulisa Anti-Human Tissue Transglutaminase (Hu-Ttg) Antibody Iga Elisa	Immco Diagnostics, Inc.	MVM	Class II	2003-12-24
K032194	Tigris Dts Automated Analyzer for Automating Amplified Nucleic Acid Test Assays	Hologic, Inc.	LSL	Class II	2003-12-24
K031869	Siss Inc. (D.b.a. Medisiss) Reprocessed Electrosurgical Instruments and Accessories	Surgical Instruments Service and Savings, Inc.	GEI	Class II	2003-12-24
K033847	A1cnow for Home and Professional Use	Metrika, Inc.	LCP	Class II	2003-12-23
K033832	Syngo Perfusion-CT	Siemens AG Medical Solutions	JAK	Class II	2003-12-23
K033712	Modification to Sectra Ids5 Radiology Workstation - Version 10.1	Sectra-Imtec AB	LLZ	Class II	2003-12-23
K033695	Irrigation Channel Tubing, Model 100135	Byrne Medical, Inc.	OCX	Class II	2003-12-23
K033541	Long Love Condom	Unidus Corp.	HIS	Class II	2003-12-23
K033383	Triage Bnp Test for the Beckman Coulter Immunoassay Systems, Model Catalog #98200	Biosite Incorporated	NBC	Class II	2003-12-23
K033360	Diazyme Lithium Enzymatic Assay Kit	General Atomics	JII	Class II	2003-12-23
K033343	Trilogy Radiotherapy Delivery System	Varian Medical Systems, Inc.	IYE	Class II	2003-12-23
K033113	Universal Operating Hysteriscope Set by Solima-Zupi, Consisting of Optic, Inner and Outer Sheaths, Forceps, Model 8753	Richard Wolf Medical Instruments Corp.	HIH	Class II	2003-12-23
K033046	Subtalar Peg Implant	Nexa Orthopedics, Inc.	MJW	Class II	2003-12-23
K033045	Dream Bond, Dreamcast Chrome, Dreamcast V, Dream Flexicast, Dream Lithecast	American Green Dent. Mfg, Inc.	EJH	Class II	2003-12-23
K033023	Intermittent Urethral Catheters	Rusch Intl.	KOD	Class II	2003-12-23