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 , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| 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 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K043175 | Elecsys Cortisol Test System, Addition of Saliva Sample Type | Roche Diagnostics GmbH | NHG | Class II | |
| K043112 | Ge 0.2T Signa Profile Excite Mr System | General Electric Co. | LNH | Class II | |
| K043096 | Commander II | Cardiocom, LLC | DXN | Class II | |
| K043052 | Trigen Hindfoot Fusion Nail | Smith & Nephew, Inc. | HSB | Class II | |
| K042996 | Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide Wire | Volcano Therapeutics, Inc. | DQX | Class II | |
| K042995 | X-Leonardo | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K042968 | Mcl 30 Dermablate Er:yag Laser System | Asclepion Laser Technologies GmbH | GEX | Class II | |
| K042960 | Given Diagnostic System with Pillcam Eso | Given Imaging Ltd. | NSI | Class II | |
| K042865 | Liquichek Urine Toxicology Control, (Levels S1s and S2s) | Bio-Rad | DIF | Class I | |
| K042859 | Kobra Gps Fixation System | Medtronic Vertelink, Inc. | KWQ | Class II | |
| K042806 | Quadrant Unit-1-Bond | Cavex Holland B.V. | KLE | Class II | |
| K042769 | Adseal Root Canal Sealer | Meta Biomed Co., Ltd. | KIF | Class II | |
| K042466 | X-2 Implant Abutment; Bar Male; Distal Extension Male | Zest Anchors LLC | NHA | Class II | |
| K042443 | Spotchem Hdl, Total Cholesterol and Triglyceride Reagent Tests and Panel | Arkray, Inc. | CHH | Class I | |
| K042400 | Mucotrol Concentrated Oral Gel Wafer | Belcher Pharmaceuticals, Inc. | OLR | Unclassified | |
| K042353 | Axis I (1Mp), II (2Mp), III (3Mp), and V (5Mp) Monochrome Displays | National Display Systems | LLZ | Class II | |
| K042340 | Kasios Tcp | Kasios Biomaterials | MQV | Class II | |
| K042264 | Guidewires | Rocket Medical | DQX | Class II | |
| K042133 | Dry Laser Imager, Model Drypro Model 793 | Konica Minolta Medical & Graphic, Inc. | LMC | Class II | |
| K042089 | Nx Stage Water Purification System | NxStage Medical Inc | FIP | Class II | |
| K042043 | Fujinon Inc. G5 Gastroscopes, Models Ec-450Wr5, Ec-250Wr5 | FUJIFILM Healthcare Americas Corporation | FDS | Class II | |
| K041747 | Impact Test System Saliva Test Module-Opiate (Workplace) | Lifepoint,Inc | DJG | Class II | |
| K041427 | The Polymedco Spotchem Ex Glucose, Fructosamine and Ast Tests | Arkray, Inc. | CGA | Class II | |
| K040328 | 15.5F Jet Medical Free Flow Long-Term Coaxial Catheter | Medcomp | MSD | Class II | |
| K043095 | Roche Diagnostics Elecsys Afp Calset II | Roche Diagnostics GmbH | JIT | Class II | |
| K043082 | The Tosca Anterior Cervical Plate System | Signus Medizintechnik GmbH | KWQ | Class II | |
| K043061 | The Trabecular Metal Glenoid - Bigliani/flatow the Complete Shoulder Solution, Model 4316-Xx-Xx | Zimmer Trabecular | KWS | Class II | |
| K042987 | Modification to Synthes Cranial Plates | Synthes (USA) Products LLC | JEY | Class II | |
| K042883 | Size 1 Triathlon Cruciate Retaining (Cr) Tibial Insert | Howmedica Osteonics Corp | JWH | Class II | |
| K042872 | Rondoflex Plus 360 | Kavo America | KOJ | Class II | |
| K042773 | Rostam Scented and Unscented Plastic Applicator Tampons | Rostam, Ltd. | HIL | Class II | |
| K042702 | Silhouette Spinal Fixation System | Zimmer Spine, Inc. | NKB | Class II | |
| K042665 | Smart Bitebloc | Oridion Medical 1987 Ltd. | CCK | Class II | |
| K042640 | Uni-Thread Spinal System | Spine Vision, Inc. | MNH | Class II | |
| K042544 | Uniplate Anterior Cervical Plate System | DePuy Spine, Inc. | KWQ | Class II | |
| K041978 | Reprocessed Diamond Burs | Alliance Medical Corp. | NLN | Class II | |
| K041928 | Hdl-Advance Assay, Cat. No. 278-20, 278-50A, 278-50B | Sekisui Diagnostics P.E.I. Inc. | LBS | Class I | |
| K041927 | Ldl/advance Assay, Cat. No. 279-20, 279-40 | Sekisui Diagnostics P.E.I. Inc. | MRR | Class I | |
| K041926 | Hdl/ldl-Advance Calibrator, Cat. No. Se-278 | Sekisui Diagnostics P.E.I. Inc. | JIX | Class II | |
| K041882 | Flowcare System | Pointcare Technologies, Inc. | GKZ | Class II | |
| K041746 | Impact Test System; Saliva Test Module-Opiate (Prescription Use) | Lifepoint,Inc | DJG | Class II | |
| K041388 | Combination Powered Electrical Muscle Stimulator and Interferential Stimulator, Model Bmls04-1 | BioMedical Life Systems Inc. | GZJ | Class II | |
| K041142 | Randox Cannabinoids Asssay | Randox Laboratories, Limited | LDJ | Class II | |
| K033146 | Tono-Pen Tonometer Tip Cover | Tra & Accessories | HKY | Class II | |
| K031568 | Biconite Surface Treatment | Bicon, LLC | DZE | Class II | |
| K043138 | Provox Nid Voice Rehabilitation System, Model Ref 7101 to 7134 | Atos Medical AB | EWL | Class II | |
| K042964 | Mx Monoaxial Pedicle Screw | Scient'X | MNH | Class II | |
| K042953 | Modification to Protex Stabilization System | Globus Medical, Inc. | NKB | Class II | |
| K042942 | Mgp 15 Dicom Theater | Barco NV Barcoview | LLZ | Class II | |
| K042918 | Microprobe Laser and Endoscopy System, Model E2 | Endooptiks, Inc. | GEX | Class II |