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 |
|---|---|---|---|---|---|
| K073277 | Roche-Creactive Protein (Latex) | Roche Diagnostics GmbH | DCN | Class II | |
| K073185 | Apx21 | Techdent Technologies, Ltd. | LQY | Unclassified | |
| K072421 | K-Y Brand Yours+mine | Mcneil-Ppc, Inc. | NUC | Class II | |
| K072214 | Portable Ventilator, Model Epv-100 | Allied Medical LLC | BTL | Class II | |
| K072163 | Happyneb II, Happyneb III, Speedy, Nebby Plus and Myneb, Model 5 | 3A Health Care S.r.l. | CAF | Class II | |
| K071242 | Dbest One Step Occult Blood Test Kits | Ameritek USA, Inc. | KHE | Class II | |
| K070800 | Lifestyles Lubricated Polyisoprene Latex Male Condom | Ansell Healthcare Products LLC | MOL | Class II | |
| K080471 | Radio Bioaquacare | Bioartificial Gel Technologies (Bagtech), Inc. | FRO | Unclassified | |
| K080340 | Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing Spike and 1000 Ml Waer Bag | Novartis Nutrition Corp. | KNT | Class II | |
| K080322 | Hy*tec Extended Specific Ige Eia, Mcs Assay Using Tecan Freedom Evo Rsp 200 | Hycor Biomedical | DHB | Class II | |
| K080193 | Synergeyes Hybrid Contact Lenses-Daily Wear | Synergeyes, Inc. | HQD | Class II | |
| K080066 | Vflex Powder Free Nitrile Examination Glove (Blue, White, Pink, and Gray Color) | Gx Corporation Sdn Bhd | LZA | Class I | |
| K073659 | Xtrac Ultra 2, Model Al10000 | Photo Medex, Inc. | GEX | Class II | |
| K073589 | Bd Phoenix Automated Microbiology System-Daptomycin (0.0313-16 Ug/ml) Steptococcus Id/ast or Ast Only Phoenix Panels | Becton Dickinson & Co | LON | Class II | |
| K073553 | Camlog Implant System Abutments | Altatec GmbH | NHA | Class II | |
| K073552 | Laborie Urodynamic System with Tetra Accessory | Abbott Medical | FEN | Class II | |
| K073544 | Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam Embolization Particles | Rj Medical, Inc. | KRD | Class II | |
| K073507 | Anchorage Access Kit | Epitek, Inc. | ODC | Class II | |
| K073474 | Capiox Circuit Connectors | Terumo Corp. | DTL | Class II | |
| K073299 | Blue Latex Exam Gloves Non Sterile Chlorinated Powder Free | Betel Care Sdn. Bhd. | LYY | Class I | |
| K073279 | Vs-Visionsense Stereoscopic Vision System | Visionsense, Ltd. | GCJ | Class II | |
| K073276 | Iontophoresis System | Acclarent Inc | EGJ | Class II | |
| K073164 | Ivs Tunneller Devices | Covidien UK Manufacturing, Ltd. | FTL | Class II | |
| K073118 | Prodigy Voice Blood Glucose Monitoring System | Diagnostic Devices, Inc. | NBW | Class II | |
| K072944 | Quanta Lite Ccp3.1 Igg/iga Elisa | Inova Diagnostics, Inc. | NHX | Class II | |
| K071779 | Abx Pentra Urine Cal | Horiba Abx | JIX | Class II | |
| K071244 | Medline Single Patient Use Blood Pressure Cuff | MEDLINE INDUSTRIES, LP - Northfield | DXQ | Class II | |
| K070965 | Alicia Menstrual Cup | Alicia International Pty, Ltd. | HHE | Class II | |
| K080494 | Baxano Ultra Low Profile Rongeur | Baxano, Inc. | HAE | Class II | |
| K073627 | Flexor Evac Aspiration Catheter | Cook Inc. | QEZ | Class II | |
| K073509 | Twinfix Pk Fp Suture Anchor | Smith & Nephew, Inc. | HWC | Class II | |
| K073156 | Qplaque Mr | Medis Medical Imaging Systems, B.V. | LNH | Class II | |
| K072793 | Liposat Basic (Infiltration Pump), Model 92-007 688 | Moeller Medical GmbH & Co. KG | QPB | Class II | |
| K070355 | Fotona Fidelis III Er:yag/nd:yag Laser System Family | Fotona D.D. | GEX | Class II | |
| K080035 | LED Curing Light | Monitex Industrial Co., Ltd. | EBZ | Class II | |
| K073647 | Minitape Extra Urethral Sling | Mpathy Medical Devices, Ltd. | OTN | Class II | |
| K073485 | Vistakon (Narafilcon) a Soft Contact Lens | Johnson & Johnson Vision Care, Inc. | LPL | Class II | |
| K073405 | Plexur M | Osteotech Inc | MQV | Class II | |
| K073339 | Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm Luer Connector | Fenwal Inc | BRZ | Class II | |
| K073119 | Clever Chek Model Td-4232 Blood Glucose Monitoring System | Taidoc Technology Corporation | NBW | Class II | |
| K072816 | Niox Mino | Aerocrine AB | MXA | Class II | |
| K072459 | Omnilux New-U | Photo Therapeutics Limited | OHS | Class II | |
| K080421 | Heart Sync, Models C-100 and T-100 | Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | MKJ | Class III | |
| K080229 | 5.5 Mm Suture Lock Bone Screw Anchor | Kfx Medical | MBI | Class II | |
| K080176 | Aloka Prosound 6 Diagnostic Ultrasound System | Aloka Co., Ltd. | IYN | Class II | |
| K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | PHX | Class II | |
| K073540 | Atlantis Abutment in Zirconia for Biohorizons Implant | Atlantis Components, Inc. | NHA | Class II | |
| K073418 | Syngo Imaging Ccf Va10a | Siemens AG Medical Solutions | LLZ | Class II | |
| K073402 | Synthes Olecranon Osteotomy Nailing System | Synthes (USA) Products LLC | HSB | Class II | |
| K073380 | Synthesis Ph.i.s.i.o. Adult Membrane Oxygenator with Integrated Areterial Filter and Hardshell Venous/cariotomy Reservoi | Corcym Inc. | DTZ | Class II |