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 |
|---|---|---|---|---|---|
| K070145 | Powdered Vinyl Patient Examination Gloves | Wuxi Shenzhou Plastic Products Co., Ltd. | LYZ | Class I | |
| K063871 | D-Stat Handle, Model 8500-053 | Vascular Solutions LLC | DXC | Class II | |
| K063471 | Shijiazhuang Junfei Plastics Products Co., Ltd. Powder Free (White) Vinyl Patient Examination Gloves | Shijiazhuang Junfei Plastic Products Co., Ltd. | LYZ | Class I | |
| K063465 | Champion Iontophoretic Drug Delivery Device | Iomed, Inc. | EGJ | Class II | |
| K063408 | Ctlogics Navigations Systems | Praxim Medivision, SA | HAW | Class II | |
| K062977 | Critiview, Model Crv3 | Critisense, Ltd. | DPW | Class II | |
| K062537 | Zoll M Series with Real CPR Help | ZOLL Medical Corporation | MKJ | Class III | |
| K062197 | Atlantis Abutment for 3I Certain Micro Mini; Gemini and Gemini+ Abutment | Atlantis Components, Inc. | NHA | Class II | |
| K070322 | Syngo Dynamics, Version 6.0 | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K063755 | Portex Hypodermic Needle-Pro Fixed Needle Syringe | Abbott Medical | MEG | Class II | |
| K063696 | Colleague Volumetric Infusion Pump Model# 2M8151,8153,8161,8163,9161,9163 | Baxterhealthcare, Inc. | FRN | Class II | |
| K063592 | Adapter Ps Rp-Np, 34551, Adapter Ps Wp-Rp,34552, Abutment Screw Ps Rp-Np, 34553, Abutment Screw Ps Wp-Rp, 34554 | Nobel Biocare AB | NHA | Class II | |
| K063570 | Biomet Tibial Locking Nail System | Biomet Manufacturing Corp | HSB | Class II | |
| K063320 | Electric Powered Lift Wheelchair, Model Vision (P13) | Imc-Heart Way LLC | ITI | Class II | |
| K063307 | Electric Powered Wheelchair, Model - Rumba Sr (4R) | Imc-Heart Way LLC | ITI | Class II | |
| K063096 | Precision Oxygen Monitor | Precision Medical, Inc. | CCL | Class II | |
| K062789 | Synthes (USA) Rapid Resorbable Fixation System | Synthes (USA) Products LLC | JEY | Class II | |
| K062764 | Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue Colored | Kossan Latex Industries (M) Sdn Bhd | LZC | Class I | |
| K061652 | Palomar Lux1540 Handpiece | Palomar Medical Products, Inc. | GEX | Class II | |
| K070319 | Gc Fuji IX Gp Extra | GC America Inc. | EMA | Class II | |
| K070085 | Balance Rehabilitation Unit (Bru) | Medicaa (Uruguay) S.A. | LXV | Unclassified | |
| K063857 | Simplex P Speedset with Tobramycin Bone Cement | Howmedica Osteonics Corp | MBB | Class II | |
| K063562 | Gynecare Prosima Pelvic Floor Repair Systems | Ethicon, Inc | OTP | Class III | |
| K063535 | Caption Applicator | Smith & Nephew, Inc. | FMF | Class II | |
| K063336 | Medela Dominant 50 Lipo, Model 600-5706 | Medela AG | QPB | Class II | |
| K063205 | Atlas Spine Vertebral Body Replacement | Atlas Spine, Inc. | MQP | Class II | |
| K062869 | Contour Curved Cutter Stapler and Reloads, Models Cs40b, Cs40g, Cr40b and Cr40g | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K062459 | Origen Dbm with Bioactive Glass | Nanotherapeutics | MQV | Class II | |
| K062350 | Surginetics Advantageblade | Surginetics | GEI | Class II | |
| K062256 | Hf54 Combination Ultrasound Interferential and Premodulated Stimulation System | Hill Laboratories | IMI | Class II | |
| K061820 | Diasorin Liaison Vzv Igg | Diasorin Inc. | LFY | Class II | |
| K070301 | Hemosil Antithrombin | Instrumentation Laboratory Co. | JBQ | Class II | |
| K070280 | Cardioday, Version 2.0 | Getemed Medizin- und Informationstechnik AG | DQK | Class II | |
| K070268 | Signature Edition Infusion System, Models 710X, 720X | Cardinal Health 303,Inc. | FRN | Class II | |
| K070260 | Star St and Arrhythmia Software, Release H.0 | Philips North America LLC | DSI | Class II | |
| K070199 | Retic-Chex Linearity for Bc | Streck LLC | JPK | Class II | |
| K070197 | Acumen Lead Delivery Sheath with Stylet, Models Lds-10-64-Sty and Lds-10-57-Sty | Acumen Medical, Inc. | DYB | Class II | |
| K070149 | Powder-Free Vinyl Patient Examination Gloves | Wuxi Shenzhou Plastic Products Co., Ltd. | LYZ | Class I | |
| K070107 | Pari Hydrate G | Pari Innovative Manufacturers, Inc. | BTT | Class II | |
| K070042 | Powdered Vinyl Patient Examination Gloves, Yellow | Super Safe Plastic Products Co., Ltd. | LYZ | Class I | |
| K063777 | Able Glove Nitrile Blue Powder Free Examination Glove | Bright Element Sdn Bhd | LZA | Class I | |
| K063754 | Dimension Vista (Tm) Bhcg Flex(r) Reagent Cartridge, and Bhcg Calibrator, Model# K6430,kc632 | Siemens Healthcare Diagnostics Inc. | DHA | Class II | |
| K063608 | Dimension Vista Apoa1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and Control Medium and High | Siemens Healthcare Diagnostics Inc. | MSJ | Class I | |
| K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | PHX | Class II | |
| K063399 | Aleutian Spacer System | K2M, Inc | MQP | Class II | |
| K063268 | Cpap/vpap Masks, Models 1225, 1205 and 1235 | Hsiner Co., Ltd. | BZD | Class II | |
| K063100 | Atlantis Anterior Cervical Plate System, Translational Plate | Medtronic Sofamor Danek | KWQ | Class II | |
| K063023 | 3M Health Care Particulate Respirator and Surgical Mask, Model 1870 | 3M Company | MSH | Class II | |
| K062852 | Balloon Expandable Transseptal Indroducer, Models Beti-1840 and Beti-1870 | Onset Medical Corporation | DYB | Class II | |
| K062263 | Omron Micro-Air Vibrating Mesh Nebulizer, Model Ne-U22 | Omron Healthcare Co., Ltd. | CAF | Class II |