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 |
|---|---|---|---|---|---|
| K050744 | Kavo Ergocom/ergocam | Kavo America | LLZ | Class II | |
| K050716 | Iscience Surgical Viscoinjector | Iscience Surgical Corporation | MRH | Class II | |
| K050703 | Qbrain | Medis Medical Imaging Systems, B.V. | LLZ | Class II | |
| K050691 | R. Poon Medical Products Wheelchairs | R. Poon Medical Products Co., Ltd. | IOR | Class I | |
| K050636 | Synthes 3.0Mm Headless Compression Screws | Synthes (USA) Products LLC | HWC | Class II | |
| K050633 | Trial Cable Retention Clip | Abbott Medical | GZB | Class II | |
| K050616 | 21.3-Inch (54Cm) Color Lcd Monitor, Models Cdl2113a, Ccl250i & Dv2mc-Hb | Totoku Electric Co., Ltd. | LLZ | Class II | |
| K050615 | Stryker Navigation System - CT-Based Hip Module, Model 6007-621-000 | Stryker Corp. | HAW | Class II | |
| K050588 | Verteview Anterior Cervical Plate System | Innovative Spinal Design, LLC | KWQ | Class II | |
| K050576 | Microalbumin Tia Reagent; Malb Calibrator Set 200; Malb Control-L, Control-H | Good Biotech Corp. | DDZ | Class II | |
| K050560 | Eurochair | Meyra, Inc. | IOR | Class I | |
| K050404 | Intuitive Surgical Da Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | HET | Class II | |
| K050357 | Camceram Tcp | Cam Implants B.V. | MQV | Class II | |
| K050030 | Acticoat Moisture Control Dressing | Smith & Nephew, Inc. | FRO | Unclassified | |
| K043531 | Modification to Arm Blood Pressure Monitor, Models Kp-6821, Kp-6822 | K-Jump Health Co., Ltd. | DXN | Class II | |
| K041579 | Medela Single Use Silc Cup, Model 077.0791 | Medela AG | HDB | Class II | |
| K050895 | Surpasson P5 Newtron | Satelec | ELC | Class II | |
| K050801 | Uriscan Optima II Urine Analyzer | YD Diagnostics | JIL | Class II | |
| K050725 | Protege Gps Self-Expanding Nitinol Stent | Medtronic, Inc. | FGE | Class II | |
| K050723 | Mg II Total Knee System Stemmed Tibial Baseplate Components | Zimmer GmbH | JWH | Class II | |
| K050647 | All-in-One | Bisco Inc | KLE | Class II | |
| K050580 | Smith & Nephew Intelijet Fluid Management Systems | Smith & Nephew Endoscopy, Inc. | HRX | Class II | |
| K050695 | Flex Controlled Phototherapy Equipment | The Daavlin Distributing Co. | FTC | Class II | |
| K050258 | Groovy Implants | Nobel Biocare AB | DZE | Class II | |
| K050165 | Modification to Ifl Professional System, Model C100 | Cyden Limited | GEX | Class II | |
| K042721 | Kolibri Spine | Brainlab, Inc. | HAW | Class II | |
| K050724 | Sure-Point Midline Stepping and Stabilization System | C.R. Bard Inc | ITX | Class II | |
| K050707 | Lerado, Avanticare Transport Wheelchair, Mt-3000 | Lerado Oversea Ltd. Twn Branch (Bvi) | IOR | Class I | |
| K050553 | Novel Vbr Spinal System | Alphatec/Nexmed | MQP | Class II | |
| K050321 | Ontrak Testcard 9 | Varian, Inc. | DIO | Class II | |
| K050310 | Bardport Titanium Ports | Bard Access Systems, Inc. | LJT | Class II | |
| K050122 | Powder Free Nitrile Examination Glove (Blue) (This Product Does Not Contain Thiuram, And/or Carbamate And/or Thiazole) | Smart Glove Corp. Sdn Bhd | LZA | Class I | |
| K043538 | Hypertransit Infusion Catheter | Cordis Neurovascular, Inc. | KRA | Class II | |
| K043356 | Wagner Sl Revision Stem Lateral | Centerpulse Orthopedics, Inc. | LZO | Class II | |
| K043339 | Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070Lg, 2770Lg, 3570Lg, 4570Lg | Xtremi-T, LLC | HTY | Class II | |
| K043083 | Advance Ha Coated Spiked Tibial Base and Advance Ha Coated Modular Keel | Wrightmedicaltechnologyinc | MBH | Class II | |
| K042449 | Dolphin Inflation Device | Sedat S.A. | MAV | Class II | |
| DEN050003 | Paxgene Blood RNA System | Preanalytix GmbH | NTW | Class II | |
| DEN050001 | Decapinol Oral Rinse | Sinclair Pharmaceuticals Ltd | NTO | Class II | |
| K050706 | Harmony Port System, Model 1907 Series | Spinal Concepts, Inc. | GZT | Class II | |
| K050700 | Matrix Stretch Resistant (Sr) Coils | Boston Scientific Corporation | HCG | Class II | |
| K050699 | Modification to: Vented Cement Restrictor, Model 60102-000-001/004 | Amedica Corp. | JDK | Class II | |
| K050604 | Kerr Vps Impression Material | Sybron Dental Specialties, Inc. | ELW | Class II | |
| K050601 | Smartdop 45 Vascular Doppler | Koven Technology, Inc. | DPW | Class II | |
| K050506 | Primasolo One-Piece Implants & Healing Caps | Lifecore Biomedical LLC | DZE | Class II | |
| K050358 | Artherx Corkscrew Ft II Suture Anchor | Arthrex GmbH | HWC | Class II | |
| K050254 | Spectra-Sp CO2 Laser System | Max Engineering, Ltd. | GEX | Class II | |
| K050153 | Spirit, Model Has | Caire, Inc. | BYJ | Class II | |
| K050101 | The Trabecular Metal Bone Stabilization Implant, Model 99-11197-Xx-10 | Zimmer Trabecular | HRS | Class II | |
| K043500 | Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad Introducer Needle | Innospine, Inc. | BSP | Class II |