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 |
|---|---|---|---|---|---|
| K142057 | Infix Cannulated Screw System | Infix Medical, LLC | HWC | Class II | |
| K141024 | External Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | DQA | Class II | |
| K143588 | Surefire Infusion System 021 | Surefire Medical, Inc. | DQO | Class II | |
| K143522 | Presto Inflation Device | C.R. Bard Inc | MAV | Class II | |
| K143223 | CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT | Toshibamedical Systems Corporation | JAK | Class II | |
| K142914 | DacryoCATH | Armadillo Biomedical, LLC | OKS | Unclassified | |
| K142641 | Intelliwave4 | Art Optical Contact Lens, Inc. | LPL | Class II | |
| K140984 | Tango3 Water Storage Tank with Ozone Disinfection System | Tango3, LLC | FIN | Class II | |
| K143594 | VaPro Pocket | Hollister Incorporated | GBM | Class II | |
| K143334 | Range/Denali/Mesa Spinal System | K2M, Inc | NKB | Class II | |
| K143225 | INFX-8000V with Wireless Footswitch | Toshibamedical Systems Corporation | OWB | Class II | |
| K143189 | t:flex Insulin Delivery System | Tandem Diabetes Care, Inc. | LZG | Class II | |
| K142974 | Extension Sets | Abbott Medical | FPA | Class II | |
| K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit | Straumann USA, LLC | NHA | Class II | |
| K142635 | Medline Silicone Foley Catheter | MEDLINE INDUSTRIES, LP - Northfield | EZL | Class II | |
| K142554 | Revolution Full Face Mask | Respironics, Inc. | BZD | Class II | |
| K142366 | Puritan OptiTranz Liquid Stuart Collection and Transport System | Puritan Medical Products Company, LLC | JSM | Class I | |
| K142363 | Nustat, Nustat Xr | Beeken Biomedical LLC | QSY | Unclassified | |
| K142059 | Fox Mobile | Vectura GmbH | CAF | Class II | |
| K141783 | Tdx Sp2 Power Wheechair | Invacare GmbH | ITI | Class II | |
| K141622 | Illuminated Mediastinoscope | Aegis Surgical, Ltd. | EWY | Class II | |
| K141465 | Cardiogard Emboli Protection Cannula | Cardiogard Medical, Ltd. | DWF | Class II | |
| K141441 | Menntor X7 | Mennen Medical, Inc. | DSI | Class II | |
| K141398 | Pass Lp Spinal System | Medicrea International | NKB | Class II | |
| K141253 | New Era Orthopaedics Polyscrew Pedicle Screw System | New Era Orthopaedics, LLC | MNI | Class II | |
| K141132 | Astroglide Ttc Fertility Friendly Personal Lubricant | Biofilm, Inc. | PEB | Class II | |
| K141114 | Bioplex(r) 2200 25-Oh Vitamin D Kit, Bioplex(r) 2200 25-Oh Vitamin D Calibrator Set, and Bioplex(r) 2200 25-Oh Vitamin D | Bio-Rad Laboratories Inc. | MRG | Class II | |
| K140046 | Spinous Process Fusion (Spf) Plate | Spinal Simplicity, LLC | PEK | Class II | |
| K133130 | Beacon Tip Torcon Nb Advantage Catheter, Torcon Nb Advantage Catheter | Cook Inc. | DQO | Class II | |
| K143757 | ANUTRA Feedback Aspiration Syringe | Anutra Medical, Inc. | FMF | Class II | |
| K143483 | MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING | Sebia, Inc. | CFF | Class II | |
| K143481 | IntellaMap Orion High Resolution Mapping Catheter | Rhythmia Medical, Inc. | DRF | Class II | |
| K143220 | SIDEKICK EZ FRAME External Fixation System | Wrightmedicaltechnologyinc | KTT | Class II | |
| K143022 | BioHorizons Tapered Internal Implants | BioHorizons Implant Systems Inc | DZE | Class II | |
| K142946 | Tiva | Becton Dickinson Infusion Therapy Systems Inc. | JKA | Class II | |
| K142712 | Dental Collagen Wound Dressing (Nova Tape and NovaPlug) | Novabone Products, LLC | KGN | Unclassified | |
| K142539 | EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set | Zevex, Inc. | PIF | Class II | |
| K142529 | Genesis Reusable Rigid Container System | Medtronic, Inc. | KCT | Class II | |
| K142350 | Pk J-Hook | Gyrus ACMI, Inc. | GEI | Class II | |
| K142297 | Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set | Xeridiem (Formerly Mri) | PIF | Class II | |
| K142152 | Construx Mini Peek; Spacer System, Ti Spacer System, Cervical Stand Alone System | Orthofix SRL | ODP | Class II | |
| K142136 | Accucath Midline Catheter System | Vascular Pathways, Inc. | FOZ | Class II | |
| K142075 | Bi-Funnel Gastrostomy Feeding Tube, Tri-Funnel Gastrostomy Feeding Tube | Xeridiem (Formerly Mri) | PIF | Class II | |
| K142034 | 3M Steri-Vac Sterilizer/aerator | 3M Company | FLF | Class II | |
| K141857 | CrossTie Intraosseous Fixation System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | HWC | Class II | |
| K141596 | Nutra Stim Hair Laser Comb | Nutra Luxe MD, LLC | OAP | Class II | |
| K141588 | Nutra Stim Hair Laser Comb | Nutra Luxe MD, LLC | OAP | Class II | |
| K140671 | Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone | Omega Laboratories, Inc. | DJG | Class II | |
| K140237 | Disposable Nebulizer Set | Suzhou Weikang Medical Apparatus Co., Ltd. | CAF | Class II | |
| K133412 | S200, S300 | Cefla S.C. | EIA | Class I |