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 |
|---|---|---|---|---|---|
| K090503 | Zquiet Mouthpiece | Sleeping Well, LLC | LRK | Class II | |
| K090502 | Nova Safe Scalp Vein Blood Collection Set | U.S. Safety Syringes Co., Inc. | FOZ | Class II | |
| K090395 | Fora Ir20b Ear Thermometer, Model Td-1261F, Fora Ir21b Ear Thermometer, Model Td-1261E | Taidoc Technology Corporation | FLL | Class II | |
| K083749 | Cardioview32 Review Module | VectraCor, Inc. | LOS | ||
| K083677 | Physioglove for Use with Physioglove Es1 | Commwell, Ltd. | DRX | Class II | |
| K083532 | Adx4000-L, Dx3000-L | Dexcowin Co., Ltd. | MUH | Class II | |
| K083206 | Lousebuster | Larada Sciences Inc. | LJL | Class I | |
| K083015 | Powder-Free Vinyl Patient Examination Gloves | Zibo Goldenline Plastic Product Co., Ltd. | LYZ | Class I | |
| K082899 | Dynamipeak Peak Flow Meter | Dynamitech Medical, Inc. | BZH | Class II | |
| K090419 | Sils Stitch Endoscopic Suturing Device | Covidien Lp, Formerly Registered AS United States | OCW | Class II | |
| K090349 | Clearvue Prone Breast Treatment Table | Orbital Therapy, LLC | IYE | Class II | |
| K083796 | Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex Self-Aspirating Syringe, Miltex Lightweight | Miltex, Inc. | EJI | Class II | |
| K083649 | Cardius 3 X-Act | Digirad Corp. | KPS | Class II | |
| K083412 | Pathfast Hscrp | Mitsubishi Kagaku Iatron | DCN | Class II | |
| K083339 | Dimension Rxl Max with Advia Modular Automation System (Amas) | Siemens Healthcare Diagnostics Inc. | CIC | Class II | |
| K083325 | N-600X with Spd, Oximax N-600X | Medtronic, Inc. | DQA | Class II | |
| K082964 | Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version 2.5) | Prism Clinical Imaging, Inc. | LNH | Class II | |
| K082478 | Welch Allyn Cardioperfect Workstation Software (Cpws) V 1.62 | Welch Allyn Inc | BZG | Class II | |
| K081081 | Zoll E Series with Bluetooth Dial Up Networking | ZOLL Medical Corporation | MKJ | Class III | |
| K090230 | Expedium Spine System | DePuy Spine, Inc. | NKB | Class II | |
| K090084 | Elation Endovenous Laser Procedure Kit Universal Fluid Dispensing Syringe | Merit Medical Systems, Inc. | GEX | Class II | |
| K090075 | Parcus V-Lox Titanium Suture Anchor,models: 10251, 10252, 10257, 10258 | Parcus Medical, L.L.C. | MBI | Class II | |
| K090073 | D3 Dfa Metapneumovirus Identification Kit | Ortho-Clinical Diagnostics, Inc. | OMG | Class II | |
| K083908 | Black Nitrile Examination Gloves | Innovative Gloves Co;, Ltd. | LZA | Class I | |
| K083694 | Synthes (USA) 2.4 Mm Va-Lcp Two Column Volar Distal Radius Plates | Synthes (USA) Products LLC | HRS | Class II | |
| K083642 | Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners | Depuy Orthopaedics Inc. | KWA | Class III | |
| K083620 | Somnolyzer 24X7 | The Siesta Group North America | MNR | Class II | |
| K083619 | Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016, 10018-10020 | Parcus Medical, L.L.C. | HWC | Class II | |
| K083609 | Kfx Peek Bone Anchor with Pre-Attached Sutures and Inserter Handle | Kfx Medical | MBI | Class II | |
| K083558 | Medacta Total Hip Prosthesis System - Quadra C | Medacta International SA | LZO | Class II | |
| K083543 | Denovismed Dental Implant Systems | Denovis Medical, LLC | DZE | Class II | |
| K083320 | Dukal Surgical Drape; Fenestrated Dukal Surgical Drape | Dukal Corp. | KKX | Class II | |
| K083218 | Tc Endo Port | Transcardiac Therapeutics, Inc. | GCJ | Class II | |
| K082924 | Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal Acetabular Liner | Wrightmedicaltechnologyinc | KWA | Class III | |
| K082614 | Evox Electro Diagnostic Device | Abbott Medical | GWF | Class II | |
| K082528 | Snor-Scope Plus or Snor-Scope + Electronic Stethoscope System | Noble Anesthesia-Air, Inc. | DQD | Class II | |
| K081330 | Carevent Par (Public Access Resuscitator) | O-Two Medical Technologies, Inc. | BTL | Class II | |
| K081063 | Sensititre Yeastone Susceptibility Plates- Additional Antimicrobics | Trek Diagnostic Systems, Ltd. | NGZ | Class II | |
| K090504 | Csbp-001A Body Perfusion System | Toshibamedical Systems Corporation | JAK | Class II | |
| K090501 | Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1 | Biopsy Sciences, LLC | NEU | Class II | |
| K090233 | Ge Datex-Ohmeda Aisys | GE Healthcare | BSZ | Class II | |
| K090001 | V-Grip Plus Detachment Controller, Model Vg503 | Terumo Cardiovascular Systems Corporation | HCG | Class II | |
| K083776 | Corflo Anti IV Enteral Feeding Set, Model: 20-1030Aiv-Lb-S | Halyard Health | FPD | Class II | |
| K083755 | Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color, Polymer Coated, Texted with Chemotherapy Drugs | Siam Sempermed Corp., Ltd. | LZA | Class I | |
| K083702 | Trach-Assist | Mergenet Medical | BZA | Class I | |
| K083650 | Emu-Graph 4 Emulator, Model Ci 144 | Steritec Products, Inc. | JOJ | Class II | |
| K083079 | Quanta Pulse Oximeter, Model: Pulse Link 1000 or Qh100 | Quanta Computer Inc | DQA | Class II | |
| K081266 | Mercury Medical PEEP Valve | Mercury Enterprizes dba Mercury Medical | BYE | Class II | |
| K090348 | Codman Bactiseal Evd Catheter Set, Codman Bactiseal Clear Evd Catheter Set | Cerenovus, Inc. | JXG | Class II | |
| K090295 | Bodyviz, Model 100 | Visual Medical Solutions, LLC | LLZ | Class II |