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 |
|---|---|---|---|---|---|
| K003550 | Infinity Etco2 + Respiratory Mechanics Pod | Siemens Medical Solutions USA, Inc. | CCK | Class II | |
| K003085 | Concentric Guide Catheter, Models 90018, 90020 | Concentric Medical, Inc. | DQY | Class II | |
| K002454 | Breas Ha50 Humidifier, Model Ha50 | Vital Signs, Inc. | BTT | Class II | |
| K002274 | Smith & Nephew Suture Hapla Interference Screw | Smith & Nephew, Inc. | HWC | Class II | |
| K001856 | Supercross Catheter | Abbott Vascular | DQY | Class II | |
| K010419 | Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables | Masimo Corporation | DQA | Class II | |
| K010381 | D.sign 30 | Ivoclar North America, Inc. | EJH | Class II | |
| K004045 | Susceptibility Test Panel | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K003864 | Injex 50 System | Equidyne Systems, Inc. | KZE | Class II | |
| K003777 | Caris Site Marker | Artemis Medical, Inc. | FZP | Class II | |
| K003765 | Lyra G Series Surgical Laser System (Sl Series Q-Switched Nd:yag Configuration) | Laserscope | GEX | Class II | |
| K002689 | Swabsite Swabbable Valve, Model 245000 | Quest Medical, Inc | FPA | Class II | |
| K002548 | Fetal Assist | Huntleigh Diagnostics, Ltd. | HGM | Class II | |
| K002088 | Shaver Ablator | Linvatec Corporation | HRX | Class II | |
| K010358 | Vigil Serology Control Level C | Siemens Healthcare Diagnostics Inc. | JJY | Class I | |
| K010096 | Multi Care Therapeutic Vibrator | Multicept, ApS. | KXQ | Class II | |
| K003784 | Mentor Self-Cath Plus | Mentor | EZL | Class II | |
| K003590 | Grams Polyester Nonabsorbable Suture | Gramsmed, LLC | GAT | Class II | |
| K010453 | M2376a Devicelink System | Agilent Technologies, Inc. | MWI | Class II | |
| K010330 | Arrow Rediguard, 9Fr. 50Cc, Intra-Aortic Balloon Vatheter, Iab-R950-U | Arrow Intl., Inc. | DSP | Class II | |
| K004044 | Hommed Sentry III Patient Monitor System | Hommed, LLC | DQA | Class II | |
| K002489 | Intuitive Surgical Da Vinci Endoscopic Control System | Intuitive Surgical, Inc. | NAY | Class II | |
| K002468 | San Up S.a. Nebulizer Compressor, with Disposable Nebulizer, Model 3050 | San UP S.A. | BTI | Class II | |
| K002095 | Snap Model 6 | Snap Laboratories, LLC | MNR | Class II | |
| K000180 | Transanal Endoscopic Microsurgery (Tem) Combination System and Instrument Set, Instrument Set for the Transanal Endoscop | Richard Wolf Medical Instruments Corp. | HIF | Class II | |
| K010511 | Modification to: Agility Steerable Guidewires | Cordis Neurovascular, Inc. | DQX | Class II | |
| K010382 | 100 Series Oxygen Analyzer, Models 1000-E and 1000-I | Sensidyne, Inc. | CCL | Class II | |
| K010329 | Logiq 500 | General Electric Co. | IYN | Class II | |
| K010320 | Modification to Symphony Graft Delivery System | Depuyacromed | LYC | Class II | |
| K010285 | Contour Profile Laser | Sciton, Inc. | GEX | Class II | |
| K010188 | Bd Eclipse Hypodermic Needle | BD Medical Systems | FMI | Class II | |
| K010147 | Ena Eia Kit | The Binding Site | LLL | Class II | |
| K010146 | Ena Eia Kit Range | The Binding Site | LLL | Class II | |
| K003893 | Vulcan Ablator Electrosurgical Probes, Vulcan Ligament Chisel Electrosurgical Probes, Model 91000X,91002x,91300x | Oratec Interventions, Inc. | HRX | Class II | |
| K003886 | Palomar Spalight Pulsed Light System | Palomar Medical Technologies, Inc. | GEX | Class II | |
| K003875 | Ti-Replica Hip Stem | Depuy Orthopaedics Inc. | LPH | Class II | |
| K003808 | Take 1 | Sybron Dental Specialties, Inc. | ELW | Class II | |
| K003725 | 240 Parus Ultrasound Imaging Systems, Model 240 Parus | Pie Medical | IYO | Class II | |
| K003717 | Instruments for Laparoscopy 5 Mm, 10 Mm with Coloured Handle, Detachable Endodcopic Instruments 5 Mm, 10Mm (Handle, Shaf | Tekno Medical Optik-Chirurgie GmbH | GEI | Class II | |
| K003715 | Cooltouch Nd:yag Laser System, Cooltouch-II Nd:yag Laser System, Model Cooltouch, Cooltouch II | Cooltouch Corp. | GEX | Class II | |
| K003705 | Xtrac Excimer Laser System, Model Al7000 | Photo Medex, Inc. | GEX | Class II | |
| K003411 | Elecsys Testosterone Calset II | Roche Diagnostics GmbH | JIT | Class II | |
| K003362 | Astronomer+with Sld | Boston Scientific Corporation | DQK | Class II | |
| K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217 | Sigma Diagnostics, Inc. | GGC | Class II | |
| K003328 | Accuclot Control I, Model A4089 | Sigma Diagnostics, Inc. | GIZ | Class II | |
| K003059 | Laser 4Spsc340 | Pride Mobility Products Corp | INI | Class II | |
| K001708 | Profox Software, Model 920M-41 | Respironics Georgia, Inc. | DQA | Class II | |
| K010444 | Advantage Single-Use Electrosurgical Attachment-J-Hook Tip, L-Hook Tip, Corbitt Spatula Tip, Ball Tip, Needle Tip | C.R. Bard Inc | GEI | Class II | |
| K010349 | Dual Lumen Midline Catheter | Catheter Innovations, Inc. | LJS | Class II | |
| K010261 | Cardiomedics Ecp System | Cardiomedics, Inc. | DRN | Class II |