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 |
|---|---|---|---|---|---|
| K070438 | Medtronic Minimed Carelink Usb Connector, Model Nmt 7305 | Medtronic, Inc. | MRZ | Class II | |
| K070405 | Modification to Surgisis Slr Staple Line Reinforcement | Cook Biotech, Inc. | FTM | Class II | |
| K063145 | Phenobarbital, Phenytoin, Tdm Calibration Set B and Abtrol/nortrol Controls | Thermo Electron Oy | DIP | Class II | |
| K072841 | Neuviz Spiral CT Scanner System | Neusoft Medical Systems Co., Ltd. | JAK | Class II | |
| K072715 | Realhand High Dexterity Instruments | Novare Surgical Systems, Inc. | GCJ | Class II | |
| K072474 | Quikclot Ex | Z-Medica, LLC | QSY | Unclassified | |
| K072454 | Integra Radionics Interfix Patient Adapters | Integra Radionics, Inc. | IYE | Class II | |
| K072035 | Resolve Uvb Phototherapy System | Allux Medical | FTC | Class II | |
| K071814 | Light Sabre Spinal Access Device | Minrad, Inc. | KNW | Class II | |
| K071382 | Scm Cath ( Sizes Are Varying Between 16G X 2'' and 24G X 3/4'' ), Model 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77, | ShinChang Medical Co., Ltd. | FOZ | Class II | |
| K071087 | Vis-U-All II Heat-Seal Pouch and Tubing | STERIS Corporation | FRG | Class II | |
| K071049 | Dover 100% Silicone Foley Catheter with Temperature Sensor | Tyco Healthcare | EZL | Class II | |
| K072767 | Quasar Blue Light Therapy System | Silver Bay, LLC | GEX | Class II | |
| K072675 | Smith & Nephew Arthroscope | Smith & Nephew, Inc. | HRX | Class II | |
| K072668 | Vitek 2 Gram Positive Vancomycin | bioMerieux, Inc. | LON | Class II | |
| K072597 | Pro-Dense Core Decompression Procedure Kit | Wrightmedicaltechnologyinc | MQV | Class II | |
| K072401 | Disposable Powder Free Vinyl Exam Glove Yellow Color | Xuzhou Full Sun Medical Products Ltd. | LYZ | Class I | |
| K072221 | Modification to Triathlon Ts Knee System | Howmedica Osteonics Corp | JWH | Class II | |
| K072029 | Phenix Vertebral Body Replacement | New Business Development, LLC | MQP | Class II | |
| K071888 | Straumann P.004 Rc Gold Abutment for Bridges | Straumann USA, LLC | NHA | Class II | |
| K071593 | Pts Panels Chol+hdl Panel Test Strips | Polymer Technology Systems | CHH | Class I | |
| K071100 | Amniscreen Home Detection Liner Kit | Common Sense, Ltd. | CEN | Class I | |
| K070751 | Orthoblast II Dbm Demineralized Bone Matrix Paste and Putty | IsoTis OrthoBiologics, Inc. | MQV | Class II | |
| K070195 | Broadsound, Al3c34a,al7l50a, Al3c79b,al7l24b, At3p42a, At3c52b, Atl5l40b, At3p32a, At3c42b | Broadsound Corporation | ITX | Class II | |
| K063788 | Reprocessed Endoscopic Trocars and Cannulas | Stryker Sustainability Solutions | NLM | Class II | |
| K062447 | Traverse Oct Spinal Fixation System | Medtronic Sofamor Danek | KWP | Class II | |
| K072716 | Vector Vision Hip | Brainlab, Inc. | HAW | Class II | |
| K072713 | Ion Dental Resin System | Dentsply International, Inc. | EBI | Class II | |
| K072679 | P.004 Abutments | Straumann USA, LLC | NHA | Class II | |
| K072253 | Synfix-Lr Spacer | Synthes Spine Co.Lp | OVD | Class II | |
| K072225 | Angiosculpt Pta Scoring Balloon Catheter | Spectranetics Corp. | PNO | Class II | |
| K072187 | Pioneer Lowtop Spinal Rod System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MNI | Class II | |
| K071947 | Vacu-Med Blood Collection Needles | Shina Corp. | FMI | Class II | |
| K071914 | Mercury Spinal System | Spinal Elements, Inc | NKB | Class II | |
| K071713 | Clarian Glucose Stabilizer Insulin Dosing Calculator | Medical Decisions Network | NDC | Class II | |
| K071561 | Hi-Speed Turbine Handpieces, Model Gso1-B,gso2-B,gso3-B,gso1-D,gso2-D | Beijing North Pole Dental Handpiece Co., Ltd. | EFB | Class I | |
| K070955 | Acid Etched Lag Screws | Biomet Orthopedics, Inc. | HSB | Class II | |
| K070845 | Sounmed Coloposcope Colpo-99/99Plus | Sounmed, Inc. | HEX | Class II | |
| K070765 | Vis-U-All II Self Seal Pouch | STERIS Corporation | KCT | Class II | |
| K070601 | Mini Drive-Lock Dental Implant System | Intra-Lock International | DZE | Class II | |
| K070414 | Gambro Cartridge Blood Sets | Gambro Renal Products | FJK | Class II | |
| K070212 | Citop10 Guidewire, 0.014(1.4Mm Tip), Citop6 Guidewire, 0.014(1.0Mm Tip), Citop Support Accessory, 0.023(126Cm) | Ovalum, Ltd. | DQX | Class II | |
| K070146 | Abx Pentra Glucose Hk Cp, Urea Cp, Uric Acid Cp | Horiba Abx | CDQ | Class II | |
| K063295 | Acon Uti Urinary Tract Infection Test Strips | Acon Laboratories, Inc. | LJX | Class I | |
| K072573 | Vectorvision Hip and Hip Sr | Brainlab, Inc. | HAW | Class II | |
| K072462 | Wide Spaced Quattrode Leads | Abbott Medical | GZB | Class II | |
| K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | DQA | Class II | |
| K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | MAX | Class II | |
| K071934 | Marrowstim Concentration Kit and Marrowstim Mini Concentration Kit | Biomet Manufacturing Corp | JQC | Class I | |
| K071146 | Vidas B.r.a.h.m.s. Pct Assay | bioMerieux, Inc. | NTM | Class II |