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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K151265 | SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System | SD Biosensor, Inc. | NBW | Class II | |
| K151191 | OES ELITE Telescopes, Protective Tube | Olympus Winter & Ibe GmbH | FBP | Class II | |
| K151125 | AVAflex Vertebral Balloon System | Care Fusion | HRX | Class II | |
| K150618 | PENTAX Medical EPK-i7010 Video Processor with GI Family | PENTAX of America, Inc. | PEA | Class II | |
| K150550 | SilverCoat Silicone Foley Catheter | Covalontechnologies, Inc. | EZL | Class II | |
| K142955 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K133178 | Luxator Lx Handpiece | Directa AB | EGS | Class I | |
| K153115 | Arthrex Univers Apex, Size 5 Stem | Arthrex GmbH | KWS | Class II | |
| K153102 | QuadraSphere Microspheres | Biosphere Medical, S.A. | KRD | Class II | |
| K152762 | Fogarty Occlusion Catheter | Edwards Lifesciences LLC | MJN | Class II | |
| K152495 | Wondfo Propoxyphene Urine Test | Guangzhou Wondfo Biotech Co., Ltd. | JXN | Class II | |
| K152349 | Star+ VPS Scannable Impression Material | Danville Materials, Inc. | ELW | Class II | |
| K152272 | Arrow Endurance Extended Dwell Peripheral Catheter System | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | FOZ | Class II | |
| K152067 | Ponto bone anchored hearing system | Oticon Medical AB | MAH | Class II | |
| K152055 | Ceramax Skin Barrier Cream | Sonoma Pharmaceuticals, Inc. | FRO | Unclassified | |
| K151764 | Yamahachi Pmma Disks | Yamahachi Dental Products USA Inc. | EBG | Class II | |
| K151739 | Revision Femoral Stem | Lima Corporate S.p.A. | LZO | Class II | |
| K143704 | Advanced Air System | W & H DentalWerk Buermoos GmbH | EFB | Class I | |
| K143669 | MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter | Medgyn Products, Inc. | MQF | Class II | |
| K151034 | PainKARE | Triowave Technologies | NUH | Class II | |
| K153219 | ProFlu+ Assay | Hologic, Inc. | OCC | Class II | |
| K153086 | RX ACCUNET Embolic Protection System | Abbott Vascular | NTE | Class II | |
| K152853 | WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary | Boston Scientific Corporation | FGE | Class II | |
| K152713 | 8MP Color LCD Monitor, RadiForce RX850, RX850-AR | Eizo Corporation | PGY | Class II | |
| K152711 | Parcus GFS Naked | Parcus Medical, L.L.C. | MBI | Class II | |
| K152641 | Pi Drive Plus Motor, Extender | Stryker Corp. | ERL | Class II | |
| K152435 | PassAssist LED Light Fiber | Entellus Medical, Inc. | LRC | Class I | |
| K152434 | XprESS Multi-Sinus Dilation System | Entellus Medical, Inc. | LRC | Class I | |
| K152282 | Cam Lock Plating System | Life Spine | KWQ | Class II | |
| K152110 | e-1 etchants | E Dental Products | KLE | Class II | |
| K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System | Siemens Healthcare Diagnostics Inc. | JLW | Class II | |
| K151773 | CONCORDE Bullet Lumbar Interbody System | Medos International SARL | MAX | Class II | |
| K151770 | Libra Pedicle Screw System | Spinal Balance, Inc. | NKB | Class II | |
| K151738 | Single Use Aspiration Needle NA-U200H | Olympus Medical Systems Corp. | FCG | Class II | |
| K151692 | BioArchitects Patient Specific Cranial/Craniofacial Plate | Bioarchitects USA, LLC | GXN | Class II | |
| K151414 | IQQA Guide | Edda Technology, Inc. | JAK | Class II | |
| K150825 | Collagen Dural Regeneration Matrix | Collagen Matrix, Inc | GXQ | Class II | |
| K150698 | Gemini Sterilization Wrap | MEDLINE INDUSTRIES, LP - Northfield | FRG | Class II | |
| K150571 | 3i T3 Short Implants | ZimVie US Corp LLC | DZE | Class II | |
| K150525 | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link | Karl Storz Endoscopy-America, Inc. | HET | Class II | |
| K150514 | Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters | C.R. Bard Inc | LJT | Class II | |
| K142617 | ArcCHECK | Sun Nuclear Corporation | IYE | Class II | |
| DEN150001 | Relizorb | Alcresta, Inc. | PLQ | Class II | |
| K153101 | BladderScan Prime System | Verathon Incorporated | IYO | Class II | |
| K152829 | Visions PV.014P RX Digital IVUS Catheter | Volcano Corporation | OBJ | Class II | |
| K152304 | Tritanium PL Cage | Stryker Corp. | MAX | Class II | |
| K152259 | InFill Interbody Fusion Device | Pinnacle Spine Group, LLC | MAX | Class II | |
| K151816 | TLC-2000 Therapeutic Medical Laser System | Theralase Technologies Inc. | NHN | Class II | |
| K151791 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir | Terumo Cardiovascular Systems Corporation | DTZ | Class II | |
| K151710 | SNaP Wound Care System | Spiracur, Inc. | OKO | Class II |