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 |
|---|---|---|---|---|---|
| K090261 | Portex Tuohy Epidural Needle 17G, Portex Tuohy Epidural Needle 18G | Abbott Medical | BSP | Class II | |
| K090127 | Metatarsal Decompression Implant, Model 100 | Solana Surgical, LLC | KWD | Class II | |
| K090079 | Vivid, Models 40-A0001, 40-A0004, 40-A0006 | Progeny, Inc. | EIA | Class I | |
| K083920 | Flowpicc Catheter | Teleflex Medical | LJS | Class II | |
| K083633 | Hs II Short Fixture System | OSSTEM Implant Co., Ltd. | DZE | Class II | |
| K083628 | Glucodr Auto System | All Medicus Co., Ltd. | NBW | Class II | |
| K083557 | Bci Ww1030 Pulse Oximeter | Abbott Medical | DQA | Class II | |
| K083088 | Verigene Respiratory Virus Nucleic Acid Test | Luminex Corporation | OCC | Class II | |
| K082781 | Oec 9900 Elite | GE Healthcare Surgery | OWB | Class II | |
| K082554 | Kimguard Sterilization Wrap, Models Kc100, Kc200, Kc300, Kc400, Kc500 and Kc600 | Kimberly-Clark Corporation | FRG | Class II | |
| K082529 | Alatech Champion Vytex Lubricated Male Latex Condom | Alatech Healthcare, LLC | HIS | Class II | |
| K081938 | Acetaminophen L3k Assay, and Acetaminophen L3k Assay, Models 506-10, 506-30 | Genzyme Diagnostics P.E.I., Inc. | LDP | Class II | |
| K081509 | Monteris Medical Autolitt Laser Probe | Monteris Medical Corp | GEX | Class II | |
| K080355 | Leksell Stereotactic System with Reusable Fixation Screws | Elekta Instrument AB | HAW | Class II | |
| K090963 | Fully Automatic Electronic Blood Pressure Monitor, Model Kd-556 | Andon Health Co., Ltd | DXN | Class II | |
| K090892 | Ge Datex-Ohmeda S/5 Adu Carestation | GE Healthcare Finland Oy | BSZ | Class II | |
| K090556 | Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software | Spacelabs Healthcare Medical Equipment (Suzhou) Co | MHX | Class II | |
| K090303 | Xtend-St Nucleus Removal System, Model 9004 | Corespine Technologies, LLC | HRX | Class II | |
| K090300 | Modification to Autofuser | Ace Medical Us, LLC | MEB | Class II | |
| K090171 | Computed Tomography X-Ray System, Pax-Reve3d | E-Woo Technology | OAS | Class II | |
| K090059 | Imago C21 Diagnostic Ultrasound System | Saset (Chengdu), Inc. | IYO | Class II | |
| K082649 | Synthes 90 Degree Screwdriver | Synthes (USA) Products LLC | DZI | Class II | |
| K091084 | Maxim Menstrual Tampons & Organyc Menstrual Tampons | Cotton High Tech S.L. | HEB | Class II | |
| K091017 | Cardica Pas-Port Proximal Anastomosis System, Model Fg-000001 | Cardica, Inc. | FZP | Class II | |
| K090701 | Empress Direct | Ivoclar Vivadent, Inc. | EBF | Class II | |
| K090638 | Genadyne A4-Xlr8 Wound Vacuum System | Genadyne Biotechnologies, Inc. | OMP | Class II | |
| K090594 | Dimension Vista Immunoglobulin a Flex Reagent Cartridge (Iga), and Dimension Vista Immunoglobulin M Flex Reagent Cartrid | Siemens Healthcare Diagnostics Inc. | CFN | Class II | |
| K090569 | Modification to: Attest Rapid Readout Biological Indicator, Mode 1292 | 3M Company | FRC | Class II | |
| K090355 | Opal Seal | Ultradent Products Inc. | DYH | Class II | |
| K090228 | Roc Lumbar Plating System | Alphatec Spine, Inc. | MNH | Class II | |
| K083586 | I-Fix System | Dentis Co.,Ltd | DZE | Class II | |
| K083112 | Primado | Nakanishi Inc. | HBC | Class II | |
| K082363 | Cook Sydney Ivf Blastocyst Vitrification (K-Sibv-5000), Warming (K-Sibw-5000) Kits | William A. Cook Australia Pty, Ltd. | MQL | Class II | |
| K091121 | Orthostat | Orthocon, Inc. | MTJ | Unclassified | |
| K090809 | Mps Acacia Power Injectable Infusion Set | Mps Acacia | FPA | Class II | |
| K090778 | Mta Protective Sheet | Xylos Corporation | FTM | Class II | |
| K090222 | Pioneer Lumbar Plate System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | Class II | |
| K090205 | Bci Ww1021 Pc Application | Abbott Medical | DQA | Class II | |
| K090038 | Syngo Brevis | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K083695 | Traxodent | Premier Dental Products Co | MVL | Unclassified | |
| K083508 | Swabcap | Excelsior Medical LLC | QBP | Class II | |
| K083203 | Helios II Q-Switched Nd:yag Laser System | Laseroptek | GEX | Class II | |
| K082038 | Clarus Video Airway Endoscope, Models 30000-V and 30003-V | Clarus Medical, LLC | BTR | Class II | |
| K090905 | Addease 20Mm Binary Connector with 17 Ga. Needle | B.Braun Medical, Inc. | LHI | Class II | |
| K090822 | Advance 14Rx Rapid Exchange Pta Balloon Catheter | Cook Inc. | DQY | Class II | |
| K090236 | Dimension Vista Afp Flex Reagent Cartridge, Model 6454 | Siemens Healthcare Diagnostics Inc. | LOJ | Class II | |
| K090176 | Nuvasive Adjustable Vertebral Body Replacement System | NuVasive Inc | MQP | Class II | |
| K090131 | Ds N95 Surgical Masks and Flat Surgical | Shanghai Dasheng Health Products | MSH | Class II | |
| K083931 | Synthetic Powder-Free Exam Vinyl Gloves, Yellow/white | Quantum Co., Ltd. | LYZ | Class I | |
| K083793 | Steerable Guide Catheter | Evalve, Inc. | DRA | Class II |