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 |
|---|---|---|---|---|---|
| K142700 | InsufflatOR Needle | Gynetech Pty., Ltd. | HIF | Class II | |
| K142688 | Echotip Procore HD Ultrasound Biopsy Needle | Cook Ireland Ltd. | FCG | Class II | |
| K142638 | ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) | Innovaquartz LLC | GEX | Class II | |
| K142508 | Powder Free Yellow Vinyl Patient Examination Gloves | Zibo Huaqi Trading Co., Ltd. | LYZ | Class I | |
| K142483 | TurboSEAL Nasogastric Aspiration Tube | Turboseal, L.P. | BSS | Class II | |
| K142474 | S12 Digital Color Doppler Ultrasound System | Sonoscape Company Limited | IYN | Class II | |
| K142430 | LIFEPAK 15 monitor/defibrillator | Physio Control, Inc. | MKJ | Class III | |
| K142415 | Hi-Torque JET Guide Wire Family | Abbott Vascular | DQX | Class II | |
| K142362 | Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno. | Siemens Healthcare Diagnostics Inc. | MRG | Class II | |
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor Core | Welch Allyn Inc | MWI | Class II | |
| K142271 | Zavation Z-Link Lumbar | Zavation | OVD | Class II | |
| K142204 | Bioceptive Suction Cervical Retractor | Bioceptive, Inc. | HDC | Class II | |
| K142194 | CytoSure Urinary Access System | Emmy Medical, LLC | FAJ | Class II | |
| K142154 | Pk Needle | Gyrus ACMI, Inc. | GEI | Class II | |
| K142111 | Arcad Compressive Osteosynthesis Staple, Express Compressive Osteosynthesis Staple | Novatsep | JDR | Class II | |
| K142041 | Porosteon Phusion Metal Cervical Cage | Porosteon, Inc. | ODP | Class II | |
| K142022 | Medline Renewal Reprocessed Gyrus-Diego Sinus Application Blades | Medline ReNewal | NLY | Class I | |
| K141969 | Firststic N Introducer | Argon Medical Devices, Inc | DYB | Class II | |
| K141926 | Invia Endure Negative Pressure Wound Therapy System | Medela AG | OMP | Class II | |
| K141752 | Nxstage System One | NxStage Medical Inc | ODN | Class II | |
| K141693 | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator | Advanced Sterilization Products | FRG | Class II | |
| K140772 | Aerosure Medic | Actegy Ltd. | BWF | Class II | |
| K140668 | Platinumgmt Ipl System Cloud | Global Medical Technology S.L. | ONF | Class II | |
| K140554 | Ids-Isys 25-Hydroxy Vitamin Ds, and Ids-Isys 25 Hydroxy Vitamin Ds Control Set | Immunodiagnostic Systems Ltd. | MRG | Class II | |
| K140440 | Noris Medical Dental Implants System | Noris Medical Ltd. | DZE | Class II | |
| K133800 | Odorox(r) Idu/rx (Tm) in-Duct Models, Odorox(r) Idu/rx (Tm) Mobile Disinfection Units, Odorox(r) Slimline/rx (Tm) Slimli | Hgi Industires | FRA | Class II | |
| K132407 | Vital Signs Patch System (in Short Vsp) | Lifewatch Technologies, Ltd. | DSI | Class II | |
| K143403 | Threshold Pedicular Fixation System | Spineology, Inc. | NKB | Class II | |
| K143307 | RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector | Rayner Intraocular Lenses Limited | MSS | Class I | |
| K143186 | Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector | Erbe USA Inc | OCX | Class II | |
| K143119 | LT-300 Video Colposcope | Lutech Industries | HEX | Class II | |
| K143050 | VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws | Smith & Nephew, Inc. | HRS | Class II | |
| K143009 | Echo Bi-Metric Microplasty Hip System | Zimmer GmbH | LPH | Class II | |
| K142805 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU) | Hartalega Sdb. Bhd. | LZA | Class I | |
| K142737 | MAS PLIF Fixation system | Nu Vasive, Incorporated | NKB | Class II | |
| K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad | Medivance Inc. | DWJ | Class II | |
| K142686 | StimPad OTC | Aemed, Inc. | NUH | Class II | |
| K142631 | Hermes Medical Imaging Suite v5.5 | Hermes Medical Solutions AB | KPS | Class II | |
| K142619 | Snap Insulin Pump System | Asante Solutions, Inc. | LZG | Class II | |
| K142609 | CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine | Guangzhou Wondfo Biotech Co., Ltd. | LFG | Class II | |
| K142588 | Nitrile Powder Free Examination Glove (Blue) | Hartalega Sdn Bhd | LZA | Class I | |
| K142570 | Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink ) | Ever Light Plastic Products Co., Ltd. | LYZ | Class I | |
| K142514 | UniWeb 8.0 | Ebm Technologies Incorporated | LLZ | Class II | |
| K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene | Seaspine, Inc. | MAX | Class II | |
| K142463 | Bio2 CLM BG Bioactive Scaffold | Bio2 Technologies, Inc. | MQV | Class II | |
| K142457 | Quickie, Zippie | Sunrise Medical, Inc. | ITI | Class II | |
| K142378 | Interspinous Plate System | Precision Spine, Inc. | PEK | Class II | |
| K142342 | NacrousPowder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Nacrous Plastic Co., Ltd. | LYZ | Class I | |
| K142333 | Smart Label, Propofol | American I.V. Products, Inc. dba Aiv, Inc. | MRZ | Class II | |
| K142239 | CPS Direct MediGuide Enabled outer catheter | Abbott Medical | DQY | Class II |