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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K181339 | Altus Spine Pedicle Screw System | Altus Partners | NKB | Class II | |
| K181178 | S-mini active Fixture | Neobiotech Co., Ltd. | DZE | Class II | |
| K181095 | RF-Relief | El Global Trade Ltd. | PBX | Class II | |
| K181025 | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System | Spryson America Inc | GWN | Class II | |
| K180544 | DePuy Synthes Static Staples | Synthes (USA) Products LLC | JDR | Class II | |
| K180218 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV | Cepheid | OCC | Class II | |
| K180115 | TWBM Pump | TAIWAN BIOMATERIAL Company, Ltd. | JCX | Class II | |
| K180017 | MX40 Release C.01 | Philips North America LLC | MHX | Class II | |
| K173943 | Dental High-speed Handpiece and Accessories | Microp Technology (Taiwan), Inc. | EFB | Class I | |
| K173929 | CipherOx CRI M1 | Flashback Technologies, Inc. | PPW | Class II | |
| K172862 | Portable ECG Monitor (ECG3) | Andon Health Co., Ltd | DSH | Class II | |
| K172095 | Autokeeper | Medexel Co., Ltd. | FMI | Class II | |
| K181398 | DV-300 Aspirator | Ding Hwa Co., Ltd. | JCX | Class II | |
| K181242 | Braun BNT400 No Touch + Forehead Thermometer | Kaz USA, Inc., A Helen of Troy Company | FLL | Class II | |
| K181083 | Stryker All-PEEK Knotless Anchor System | Stryker Corp. | MBI | Class II | |
| K180854 | Voyager Trajectory Array Guide (V-TAG) | Voyager Therapeutics, Inc. | HAW | Class II | |
| K180518 | GME LinScan Lite 808 Laser System | Gme German Medical Engineering GmbH | GEX | Class II | |
| K173645 | JASPER Spinal Fixation System | Gbs Commonwealth Co., Ltd. | NKB | Class II | |
| K173444 | Quantitative Total Extensible Imaging (QTxI) | Aiq Solutions | LLZ | Class II | |
| K171888 | Non-contact infrared body thermometer | Hetaida Technology Co., Ltd. | FLL | Class II | |
| K181647 | Bandit guidewire | Vascular Solutions LLC | DQX | Class II | |
| K181636 | Aurora | Sodium Systems, LLC | MUH | Class II | |
| K181631 | Gr40cw | Samsung Electronics Co., Ltd. | MQB | Class II | |
| K181629 | Gc85a | Samsung Electronics Co., Ltd. | KPR | Class II | |
| K181626 | Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. | IZL | Class II | |
| K181585 | JGH1 Core Deccompression Procedure Kit | Agnovos Healthcare USA, LLC | MQV | Class II | |
| K181382 | GuardianTM Burr Hole Cover System | Abbott Medical | GXR | Class II | |
| K181017 | Free Testosterone AccuBind ELISA Test System | Monobind, Inc. | CDZ | Class I | |
| K180948 | TruDi NAV Suction Instruments | Acclarent Inc | PGW | Class II | |
| K180864 | WATCHMAN TruSeal Access System | Boston Scientific Corporation | DQY | Class II | |
| K180263 | EcoFit Vit E Acetabular System | implantcast GmbH | LZO | Class II | |
| K180022 | Athena Cervical Plate System | Medyssey USA | KWQ | Class II | |
| K173973 | Tv-100 | Bio-Med Devices, Inc. | CBK | Class II | |
| K173675 | AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber | ConvaTec Limited | FRO | Unclassified | |
| K173366 | NicoletOne | Medtronic, Inc. | OLZ | Class II | |
| K173188 | The Graft Natural Bone Substitute | Purgo Biologics Inc. | NPM | Class II | |
| DEN170009 | Bonebridge | Med-el Elektromedizinische Geraete, GmbH | PFO | Class II | |
| K181834 | Ultimax-i, DREX-UI80 (V1.60) | Canon Medical Systems Corporation | OWB | Class II | |
| K181623 | Clarifi Imaging System | Modulated Imaging, Inc. | MUD | Class II | |
| K181345 | Image Filing Software NAVIS-EX | Nidek Co., Ltd. | NFJ | Class II | |
| K181342 | JGH1 Bone Graft Substitute | Agnovos Healthcare USA, LLC | MQV | Class II | |
| K180763 | CuffLink Implant System Biocomposite | ConMed Corporation | MAI | Class II | |
| K180629 | DentiqGuide | 3D Industrial Imaging Co., Ltd. | LLZ | Class II | |
| K180419 | Ultrasonic Doppler (Model YM-2T8) | Shenzhen Imdk Medical Technology Co., Ltd. | KNG | Class II | |
| K173911 | Medline Burn and Wound Dressing | MEDLINE INDUSTRIES, LP - Northfield | FRO | Unclassified | |
| K173585 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. | NAY | Class II | |
| K172857 | Latitud Hip Replacement System | Meril Healthcare Pvt. Ltd. | LPH | Class II | |
| K171566 | Atellica IM High-Sensitivity Troponin I (TNIH) | Siemens Healthcare Diagnostics Inc. | MMI | Class II | |
| K170369 | Disposable Electrosurgical Pencils | Cathay Manfacturing Corp. | GEI | Class II | |
| K181376 | Arietta 65 | FUJIFILM Healthcare Americas Corporation | IYN | Class II |