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 |
|---|---|---|---|---|---|
| K072334 | Sialo Drain | Sialo Technology, Ltd. | OAJ | Class I | |
| K081716 | Advia Centaur Havm Assay | Siemens Healthcare Diagnostics Inc. | LOL | Class II | |
| K081707 | Aequalis Shoulder Fracture and Shoulder Systems | TORNIER Inc. | KWS | Class II | |
| K081700 | Synthes (USA) Sternal Fixation System - Line Extension | Synthes (USA) Products LLC | HWC | Class II | |
| K081446 | Bd Spinal Needle, Models: 405081, 405235, 405236, 405237 | Becton Dickinson & Co | BSP | Class II | |
| K081328 | Pathway Pv Atherectomy System | Pathway Medical Technologies, Inc. | MCW | Class II | |
| K081172 | Composite Hitch Suture Anchor | Biomet Manufacturing Corp | JDR | Class II | |
| K081140 | Visensia | OBS Medical Ltd | MHX | Class II | |
| K081059 | Aequalis Reversed Shoulder Prosthesis | TORNIER Inc. | PHX | Class II | |
| K080878 | Mtg Instant Cather (with and without Kit), Mtg Instant Cath Deluxe (with and without Kit) | Medical Technologies of Georgia | KOD | Class II | |
| K080744 | Hg II Fixture System | OSSTEM Implant Co., Ltd. | DZE | Class II | |
| K080731 | Pharaon 980 Endo/exo, Osyfibre 600, Control4+ Handpiece | Osyris | GEX | Class II | |
| K080450 | Stryker Power Tool Navigator Attachment | Stryker Corp. | HAW | Class II | |
| K080123 | Apolowako Hba1c, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201 | FUJIFILM Healthcare Americas Corporation | CFR | Class II | |
| K073720 | Esensor Warfarin Sensitivity and Xt-8 Instrument | Osmetech Molecular Diagnostics | ODW | Class II | |
| K072845 | Precision Flow | Vapotherm Inc. | BTT | Class II | |
| K081873 | Emp-2100 Full Digital Ultrasound Diagnostic Device | Shenzhen Emperor Electronic Technology Co., Ltd. | IYO | Class II | |
| K081841 | Amplivox Otowave 102 Hand Held Portable Tympanometer | Amplivox Ltd | ETY | Class II | |
| K081098 | Endobutton Continuous Loop (Cl) | Smith & Nephew, Inc. | JDR | Class II | |
| K080905 | Quantum/ Canon Cxdi Integration System, Model Qg-Dig-Cxdi | Quantum Medical Imaging, LLC | LLZ | Class II | |
| K080445 | Lion Se One Step Orthodontic Adhesive | Classone Orthodontics, Inc. | DYH | Class II | |
| K072977 | Diazyme Apolipoprotein a-1 Assay | General Atomics | MSJ | Class I | |
| K072741 | Pre-Va Vaginal Lubricant | Ingfertility, LLC | PEB | Class II | |
| K081905 | Accuflow and Accuflux Elastomeric Infusion Pump | Westmed Inc | MEB | Class II | |
| K081843 | Ultrasound Data Analysis System, Model Das-Rs1 | Aloka Co., Ltd. | LLZ | Class II | |
| K081437 | Mac 1600 ECG Analysis System | GE Medical Systems Information Technologies, Inc. | DPS | Class II | |
| K081389 | Accu-Chek Compact Plus Blood Glucose Monitoring System | Roche Diagnostics GmbH | NBW | Class II | |
| K081366 | Kumar T-Anchors Hernia Set | Nashville Surgical Instruments | GAR | Class II | |
| K081099 | Tephaflex Absorbable Suture | Tepha, Inc. | NWJ | Class II | |
| K081078 | Nt/it System | OSSTEM Implant Co., Ltd. | DZE | Class II | |
| K080975 | Fencer 308 Excimer Laser System | Kera Harvest/Laser Max Medical Technologies Corp | GEX | Class II | |
| K080914 | Ultrasharp Concentric Needles | Rochester Electro Medical, Inc. | IKT | Class II | |
| K080897 | Venturi Negative Pressure Wound Therapy System | Talley Medical | OMP | Class II | |
| K080633 | Screwindirect Dental Implants | Implant Direct, LLC | DZE | Class II | |
| K073115 | Orthomesh | Synthes (USA) Products LLC | HRS | Class II | |
| K072136 | Ultrasonic Nebuliser Model 2010 | Wilfred Kromker GmbH | CAF | Class II | |
| K081690 | Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter | Cook Inc. | FOZ | Class II | |
| K081418 | Spinal Elements Buttress Plate System | Spinal Elements, Inc | KWQ | Class II | |
| K081234 | Gn Otometrics Insert Earphones | Natus Medical Denmark ApS | EWO | Class II | |
| K081188 | Trilogy with External System Gating Interface | Varian Medical Systems, Inc. | IYE | Class II | |
| K081132 | Spinesmith Partners, Lp Cequence Anterior Cervical Plate System | Spine Smith Partners L.P. | KWQ | Class II | |
| K081108 | Monopoly Pedicle Screw System | Signus Medical, LLC | NKB | Class II | |
| K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim | Kimberly-Clark Corporation | LZC | Class I | |
| K080982 | Sterling Es Monorail and Over-the-Wire Pta Balloon Dilatation Catheters | Boston Scientific Corporation | LIT | Class II | |
| K072291 | Conmed Linvatec Bio Mini-Revo Suture Anchor | Conmed Linvatec | HWC | Class II | |
| K072143 | S40 Clinical Analyzer, S Test Alb | Alfa Wassermann Diagnostic Technologies, Inc. | CIX | Class II | |
| K081882 | Modification to Xylos Surgical Mesh | Xylos Corporation | FTM | Class II | |
| K081829 | Capimage | Danish Diagnostic Development A/S | IYX | Class I | |
| K081802 | Cx50 Diagnostic Ultrasound System | Philips North America LLC | ITX | Class II | |
| K081370 | Serim Disintek Opa Test Strip | Serim Research Corp. | JOJ | Class II |