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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K182017 | Compex HD | Addent, Inc. | QGO | Class I | |
| K181732 | InterSpace Knee Extra-Large Size, InterSpace Knee ATS | Tecres SpA | JWH | Class II | |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP Slides | Ortho-Clinical Diagnostics, Inc. | CIG | Class II | |
| K190464 | Penumbra System 3D Revascularization Device | Penumbra Inc. | NRY | Class II | |
| K190290 | AltiVate Reverse Humeral Stem, 48mm | Encore Medical, LP | KWS | Class II | |
| K183094 | CyclaPlex Correction System | Cycla Orthopedics, Ltd. | HTN | Class II | |
| K182830 | Cardinal HealthTM Poly-Coated Open-Back Protective Gown | Cardinal Health200, LLC | QPC | Class II | |
| K182637 | Philips IntelliVue XDS Software | Philips Medizin Systeme Boeblingen GmbH | MSX | Class II | |
| K182585 | JO Actively Trying Personal Lubricant | United Consortium | PEB | Class II | |
| K182108 | Portable Electro-Stimulation Therapy Device | Guangzhou Longest Science & Technology Co., Ltd. | NUH | Class II | |
| K190771 | Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System | Cepheid | NQX | Class II | |
| K190601 | MasteRad MX30 | Medicatech USA | KPR | Class II | |
| K190042 | Brainlab Elements Image Fusion Angio | Brainlab, Inc. | LLZ | Class II | |
| K183537 | PANAVIA SA Cement Universal | Kuraray Noritake Dental, Inc. | EMA | Class II | |
| K183248 | Synapse Enterprise Viewer Version 1.0 | FUJIFILM Corporation | LLZ | Class II | |
| K183146 | Ranfac Cartilage Biopsy Needle | Ranfac Corp. | KNW | Class II | |
| K182100 | Smile Makers Personal Lubricant | Lfbeauty (Thailand) Limited | NUC | Class II | |
| K182071 | Multi-Sideport Catheter Infusion Set | Cook Incorporated | KRA | Class II | |
| K182049 | exCellerator Cervical Collection Device | Excell Company, LLC | HHT | Class II | |
| K181787 | Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes | Cedic S.r.l. | PIF | Class II | |
| K190812 | RAYSCAN a-Expert3D | Ray Co., Ltd. | OAS | Class II | |
| K190789 | IntelliCartTM System | Dornoch Medical Systems | JCX | Class II | |
| K190496 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Cefla S.C. | OAS | Class II | |
| K190375 | Parcus ATLAS | Parcus Medical, L.L.C. | MBI | Class II | |
| K190212 | AXS Vecta Aspiration System | Stryker Corp. | NRY | Class II | |
| K190113 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags | Corinth Medtech, Inc. | HIH | Class II | |
| K190043 | Halley resin | Dentsply Sirona Inc | EBI | Class II | |
| K183679 | Occlusion Balloon Catheter | Qxmedical, LLC | MJN | Class II | |
| K183156 | V-Laser | WONTECH Co., Ltd. | GEX | Class II | |
| K182172 | Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) | MEDLINE INDUSTRIES, LP - Northfield | FYA | Class II | |
| K173065 | A&D Medical Blood Pressure Monitors | A&D Company, Ltd. | DXN | Class II | |
| DEN170064 | Comaneci, Comaneci Petit, Comaneci 17 | Rapid Medical Inc. | PUU | Class II | |
| K190753 | EverCrossTM 0.035 OTW PTA Dilatation Catheter | Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) | LIT | Class II | |
| K190621 | SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long | Sumitomo Bakelite Co., Ltd. | KNS | Class II | |
| K190489 | Elcam Stopcocks and Manifolds | Elcam Medical A.C.A.L. | FMG | Class II | |
| K190110 | NanoBone SBX PUTTY, NanoBone QD | Artoss, Inc. | MQV | Class II | |
| K182723 | Flexible HD Cysto-Urethroscope System | Karl Storz Endoscopy-America, Inc. | FAJ | Class II | |
| K182386 | Reprocessed Supreme Diagnostic Electrophysiology Catheter | Innovative Health, LLC. | DRF | Class II | |
| K181971 | Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set | Cook Incorporated | FAD | Class II | |
| K181472 | AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor | Advanced Sterilization Products (Asp) | FEB | Class II | |
| K190407 | CryoLab | Cryoconcepts LP | GEH | Class II | |
| K183613 | exGraft, exGraft Carbon | Peca Labs, Inc. | DSY | Class II | |
| K182778 | Lc Glossfill Xr | S&C Polymer Silicon- und Composite Spezialitaeten | EBF | Class II | |
| K182516 | Comprehensive Nano Stemless Shoulder | Biomet Manufacturing Corp | PKC | Class II | |
| K182513 | FluChip-8G Influenza A+B Assay | Indevr, Inc. | OZE | Class II | |
| K190791 | Ez3D-i/E3 | Ewoosoft Co., Ltd | LLZ | Class II | |
| K190729 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies ULC. (Now A Part of Stryker) | OWN | Class II | |
| K190463 | Cepheid Xpert C. difficile/Epi Control Panel | Microbiologics, Inc. | PMN | Class II | |
| K190415 | ATLAS Plating System | Mirus, LLC | HRS | Class II | |
| K183192 | CapsoCam Plus (SV-3) | CapsoVision, Inc. | NEZ | Class II |