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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K191263 | Idys ALIF TiVac | Clariance-SAS | OVD | Class II | |
| K191220 | Pure Vu System | MOTUS GI Medical Technologies Ltd. | FDF | Class II | |
| K191043 | da Vinci Handheld Camera | Intuitive Surgical, Inc. | GCJ | Class II | |
| K190827 | Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid | Uvision360, Inc. | HIH | Class II | |
| K190618 | RIGEL PEEK Anterior Cervical Interbody Fusion System | Mirus, LLC | ODP | Class II | |
| K190616 | VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL) | bioMerieux, Inc. | LON | Class II | |
| K190568 | ComPAS2 (Computerized Pulmonary Analysis System) | Morgan Scientific, Inc. | BZG | Class II | |
| K183620 | PROSTEP TBC Implant System | Wrightmedicaltechnologyinc | HRS | Class II | |
| K191307 | Palm Bladder Scanner - PBSV5.1 | Mianyang Meike Electronic Equipment Co.,Ltd. | IYO | Class II | |
| K190874 | Materialise Mimics Enlight | Materialise N.V. | LLZ | Class II | |
| K190804 | HydroCision TenJet Device | Hydrocision, Inc. | HRX | Class II | |
| K190595 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | KWT | Class II | |
| K190585 | Biocode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | PCH | Class II | |
| K190576 | WalterLorenz Surgical Assist Arm Scope Holder | Biomet Microfixation | OCV | Class II | |
| K190505 | Low Dose Lung Screening Option | Canon Medical Systems Corporation | JAK | Class II | |
| K183559 | WatchPAT ONE | Itamar Medical | MNR | Class II | |
| K183114 | Corin BiPolar-i | Corin USA | KWY | Class II | |
| K180671 | Mine | Rht Co., Ltd. | EHD | Class II | |
| K191340 | CORTRAK* 2 Equilateral Enteral Access System | Halyard Health | KNT | Class II | |
| K190892 | MectaScrew PEEK Interference Screw | Medacta International SA | MBI | Class II | |
| K190579 | TD-4183 Blood Glucose Monitoring System | Taidoc Technology Corporation | NBW | Class II | |
| K190573 | KOWA DR-1a | Kowa Company, Ltd. | HKI | Class II | |
| K190461 | Achieva 1.5T, 3.0T and Intera 1.5T MR Systems | Philips Medical Systems Nederland B.V. | LNH | Class II | |
| K190245 | PDS Barbed Suture, PDO MAXX Threads | Pdo Max | NEW | Class II | |
| K190068 | Vanguard XP Knee System | Zimmer GmbH | JWH | Class II | |
| K183535 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co., Ltd | DXN | Class II | |
| K183533 | Unity Total Knee System | Corin USA | JWH | Class II | |
| K191185 | Solanas® Posterior OCT Fixation System | Alphatec Spine, Inc. | NKG | Class II | |
| K190337 | ReWalk Restore | Re Walk Robotics, Ltd. | PHL | Class II | |
| K182625 | Diapex Plus | Diadent Group International | KIF | Class II | |
| K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors | Physio Control, Inc. | LDD | Class II | |
| K190564 | Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB | Bionime Corporation | NBW | Class II | |
| K190572 | Erchonia FX-635 | Erchonia Corporation | NHN | Class II | |
| K190896 | BriefCase | Aidoc Medical Ltd. | QAS | Class II | |
| K190831 | E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor | Nanjing Jusha Display Technology Co., Ltd | GCJ | Class II | |
| K190766 | PALACOS fast R+G | Heraeus Medical GmbH | LOD | Class II | |
| K190757 | MAGNETOM Avanto Fit | Siemens Medical Solution USA, Inc. | LNH | Class II | |
| K190565 | Cervical Plate | Eisertech, LLC | KWQ | Class II | |
| K190546 | NEXXT MATRIXX Stand Alone Cervical System | Nexxt Spine LLC | OVE | Class II | |
| K190543 | Cannulated Hemi Implant | Vilex LLC | KWD | Class II | |
| K190310 | U Deliver Bolink ENFit Enteral Feeding Sets | U Deliver Medical L.L.C. | PIF | Class II | |
| K190246 | NeuroShield | Monarch Bioimplants GmbH | JXI | Class II | |
| K190240 | Tiger Sharps Containers | International Marketing Specialists, Inc. | MMK | Class II | |
| K190194 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge | Pentax Medical, A Division of Pentax of America, Inc. | GEH | Class II | |
| K182725 | Apis | Sweetbio | FRO | Unclassified | |
| K182678 | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling | Zimmer GmbH | LPH | Class II | |
| K182443 | Pristine Hemodialysis Catheter | Pristine Access Technologies, Ltd. | MSD | Class II | |
| K191188 | Ashk100g | LG Electronics Inc. | LLZ | Class II | |
| K191145 | MasterLoc Extension | Medacta International SA | LZO | Class II | |
| K191067 | Arc Endocuff Glide AEG110 & AEG120 | Boddingtons Plastics, Ltd. | FED | Class II |