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 |
|---|---|---|---|---|---|
| K191168 | Cepheid Xpert SA Nasal Complete Control Panel | Microbiologics, Inc. | PMN | Class II | |
| K190785 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | Innovative Health, LLC. | NLG | Class II | |
| K190784 | BUHLMANN fCAL turbo | Buhlmann Laboratories AG | NXO | Class II | |
| K190779 | Trevo XP ProVue Retriever | Stryker Corp. | POL | Class II | |
| K190743 | Venus Bliss | Venus Concept USA Inc. | PBX | Class II | |
| K190052 | Radio Frequency Ablation System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | GEI | Class II | |
| K182704 | WishBone Guided Growth System | Wishbone Medical, Inc. | OBT | Class II | |
| K190927 | Oscillometric Blood Pressure Monitor | Rudolf Riester GmbH | DXN | Class II | |
| K190443 | MMSphere | Galactic Beauty, LLC | OHS | Class II | |
| K190106 | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle | Centerline Biomedical | DQK | Class II | |
| K183170 | uWS-CT | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | |
| K183032 | FUJIFILM Double Balloon Endoscope EI580BT | FUJIFILM Corporation | FDA | Class II | |
| K182411 | Scooter, Model: R-100 | Yongkang Dingchang Industry & Trade Co., Ltd. | INI | Class II | |
| K171304 | Maxxi Rip Sensor | Neurovirtual USA, Inc. | MNR | Class II | |
| K190754 | Orthoss(R) | Geistlich Pharma AG | MQV | Class II | |
| K182844 | Asahi Sasuke | Asahi Intecc Co., Ltd. | DQY | Class II | |
| K191400 | Voyager Trajectory Array Guide (V-TAG) | Mri Interventions, Inc. | HAW | Class II | |
| K191388 | FloPatch (FP110) | Flosonics Medical (R/A 1929803 ONTARIO Corp.) | DPW | Class II | |
| K191151 | JKH Stimulator Plus | JKH USA, LLC | NUH | Class II | |
| K190750 | DePuy Synthes Plates and Screws Portfolio | DePuy Synthes | HRS | Class II | |
| K190597 | BRILLIANT EverGlow Flow | Coltene /Whaledent AG | EBF | Class II | |
| K190360 | LineSider™ Spinal System | Integrity Implants, Inc. | NKB | Class II | |
| K190152 | Vit Kit- Freeze NX and Vit Kit- Warm NX | FUJIFILM Biosciences Inc. | MQL | Class II | |
| K190130 | The ClearSight finger cuffs | Edwards Lifesciences LLC | DXN | Class II | |
| K183595 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | KNS | Class II | |
| K183262 | EsoCheck CCD Cell Collection Device | Lucid Diagnostics, Inc. | EOX | Class II | |
| K183220 | OrthoScan TAU Mini C-Arm | Orthoscan, Inc. | OXO | Class II | |
| K182963 | emFieldPro | Zimmer Medizinsysteme GmbH | NGX | Class II | |
| K182960 | ReliefBand | ReliefBand Technologies | GZJ | Class II | |
| K182139 | AXTi Titanium Stand-Alone ALIF System | Innovasis, Inc | OVD | Class II | |
| K181260 | MiiS Horus Scope DPT 100 | Medimaging Integrated Solution, Inc (Miis) | HKX | Class II | |
| K191456 | Campylobacter Quik Chek | Techlab, Inc. | LQP | Class I | |
| K191442 | Campylobacter Chek | Techlab, Inc. | LQP | Class I | |
| K191172 | Cepheid Xpert MRSA NxG Control Panel | Microbiologics, Inc. | PMN | Class II | |
| K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | NKB | Class II | |
| K190336 | Soniquence Bipolar Electrodes | Soniquence, LLC | GEI | Class II | |
| K190122 | Renovis A200 PS Knee System as part of the Renovis A200 Knee System | Renovis Surgical Technologies, LLC | JWH | Class II | |
| K190095 | Powder-Free Clear Vinyl Patient Examination Gloves | Anhui Intco Medical Products Co., Ltd. | LYZ | Class I | |
| K183624 | Kubtec Mozart (Xpert42) | Kub Technologies, Inc. | MWP | Class II | |
| K183580 | Panthera Dental Milled Bars | Panthera Dental Inc | NHA | Class II | |
| K183450 | EmBody System | Inmode MD, Ltd. | PBX | Class II | |
| K183354 | Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate | Gx Corporation Sdn Bhd | LZA | Class I | |
| K182742 | Db-Cmf | Dimensional Bioceramics, LLC | GXP | Class II | |
| K182285 | PK High Tibial Osteotomy Correction System | Paonan Biotech Co., Ltd | KTW | Class II | |
| K191418 | Multix Fusion Max | Siemens Medical Solutions USA, Inc. | KPR | Class II | |
| K190889 | Republic Spine Restore Cervical Interbody Fusion System | Republic Spine | ODP | Class II | |
| K190762 | The JASPER Spinal Fixation System II | Gbs Commonwealth Co., Ltd. | NKB | Class II | |
| K190387 | RayStation | RaySearch Laboratories AB (publ) | MUJ | Class II | |
| K190115 | Mhd TENS | Minghuangda Electronic Co., Ltd. | NUH | Class II | |
| K182785 | LOQTEQ VA Foot Plates 2.5 | AAP Implantate AG | HRS | Class II |