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 |
|---|---|---|---|---|---|
| K043419 | P&p Safety Syringe | Medexel Medical Mfg. Co., Ltd. | MEG | Class II | |
| K043328 | Microflo-Safe Scalp Vein Set | Dks Loversan Industria Biomedica SpA | FPA | Class II | |
| K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | KKY | Class II | |
| K042965 | Tomas Pin | Dentaurum Inc. | OAT | Class II | |
| K042944 | Home-Away System, Model 1041 | In-X Corp. | CAW | Class II | |
| K042927 | Vacuette Edta K3 Evacuated Blood Collection Tubes | Greiner Bio-One Vacuette North America | PJE | Class II | |
| K042018 | Acute Portable Exchange Deionization (Pedi) System, Central Pedi System, Back-Up Pedi System | Simply Clean Air & Water, Inc. | FIP | Class II | |
| K041495 | Pentadeflue IV Solution Administration Sets | Pentaferte S.P.A | FPA | Class II | |
| K050867 | Syngo Body Perfusion-CT | Siemens Corp. | JAK | Class II | |
| K050770 | Modification to Accufuser, Accufuser Plus Standard Procedure Kit | Mckinley Medical, LLC | MEB | Class II | |
| K050769 | Quikclot Brand Hemostatic Agent - Advanced Beaded Formulation - 100G - 1.9Mm - 2.4Mm., Model 100172 | Z-Medica, LLC | QSY | Unclassified | |
| K050562 | Oculight Gl/glx | Iridex Corporation | GEX | Class II | |
| K050555 | Bd Phoenix Automated Microbiology System - Cefazolin (Gp) 2-32 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K050532 | Chlorinated Powder Free Latex Examination Gloves with Protein Labeling Claim (Contains 50 Micrograms or Less of Total Wa | Spi Gloves Sdn. Bhd. | LYY | Class I | |
| K050511 | Thrombigel Thrombin/gelatin Foam Hemostat | Vascular Solutions LLC | QSX | Unclassified | |
| K050474 | Veinnovations Infiltration System | Veinnovations, LLC | FRN | Class II | |
| K043614 | Vaculink, Model Vcl 3000 | Medevco, Inc. | HDB | Class II | |
| K042495 | Cumulase | Halozyme Therapeutics, Inc. | MQL | Class II | |
| K050778 | Telerehad 2004 | Scottcare Corporation | DRG | Class II | |
| K050743 | Aquaflex 2 (Tefilcon) Contact Lens | Unilens Corp., USA | LPL | Class II | |
| K050517 | Jsz-Multipurpose Solution | Szabocsik and Associates | LPN | Class II | |
| K050433 | Zimmer Ambulatory Pump Pain Management System | Zimmer Surgical SA | FRN | Class II | |
| K050181 | Medigloves Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves | Medigloves, Ltd. | KGO | Class I | |
| K050046 | Rehabilicare If 3 Wave Interferential Stimulator System, Model 7110S | Compex Technologies, Inc. | IPF | Class II | |
| K050038 | Reliant Stent Graft Balloon Catheter | Medtronic Endovascular Innovations | DQY | Class II | |
| K040757 | Sic Pro | Sic Invent AG | DZE | Class II | |
| K050831 | Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230A | Stellartech Research Corp. | GEI | Class II | |
| K050796 | Aurora Ds, Ds Applicator | Syneron Medical, Ltd. | GEX | Class II | |
| K050676 | Ge Detax-Ohmeda Anesthesia Delivery Unit (Adu) | GE Healthcare | BSZ | Class II | |
| K050483 | Evadri Bladder Control Systems | Hollister, Inc. | KPI | Class II | |
| K050343 | Reprocessed Harmonic Scalpels | Sterilmed Inc | NLQ | Unclassified | |
| K043555 | Synthes 9Usa) Alveolar Ridge Distractor | Synthes (USA) Products LLC | MQN | Class II | |
| K043385 | Osom Hcg Combo Test | Sekisui Diagnostics, LLC | JHI | Class II | |
| K042092 | Athena Multi-Lyte Ebv Vca Igm Test System | Zeus Scientific LLC | LJN | Class I | |
| K050819 | Charlotte Snap-Off Screw | Wrightmedicaltechnologyinc | HWC | Class II | |
| K050804 | Modification to: Spectrumtm Cervical Spinal System | Aesculap Inc | KWQ | Class II | |
| K050774 | Lanx Anterior Cervical Plate System | Lanx, LLC | KWQ | Class II | |
| K050761 | Zimmer Trabecular Metal Humeral Stem, Sizes 6Mm and 8Mm | Zimmer GmbH | KWT | Class II | |
| K050675 | Expedium Spine System Spinous Process Fusion Plate | DePuy Spine, Inc. | MNI | Class II | |
| K050666 | Generos, Models Go-01G, Go-05G, Go-10G, Go-15G, Go-20G, Go-30G, Go-40G, Go-60G, Go-Xyz Series, Go-Dz Series | Berkeley Advanced Biomaterials | MQV | Class II | |
| K050631 | Synthes (USA) Small Adjustable Clamp-Mr Safe Line Extension | Synthes (USA) Products LLC | LXT | Class II | |
| K050624 | Stryker Spine Avs Pl Peek Spacer | Howmedica Osteonics Corp | MQP | Class II | |
| K050607 | Synthes 1.0Mm Ti. Cortex, Self-Drilling Screws (Hand & Neuro) | Synthes (USA) Products LLC | HRS | Class II | |
| K050490 | Osmosys Calcium Phosphate Ceramic Bone Filler | Medicrea | MQV | Class II | |
| K050414 | Plix | Respironics, Inc. | BYJ | Class II | |
| K050281 | Transport Series Transport Chair | Access Point Medical, LLC | IOR | Class I | |
| K050280 | Runabout Wheelchair | Access Point Medical, LLC | IOR | Class I | |
| K050279 | Axs-1 Lite Wheelchair | Access Point Medical, LLC | IOR | Class I | |
| K050193 | Gerson 2130/31 Type N95 Niosh Certified Surgical Respirator | Louis M. Gerson Co., Inc. | MSH | Class II | |
| K043053 | Modification to Cd Horizon Spinal System | Medtronic Sofamor Danek | KWP | Class II |