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 |
|---|---|---|---|---|---|
| K021306 | Vectorvision CT-Free Knee | Brainlab, Inc. | HAW | Class II | |
| K021190 | Pt-S Test Strips for the Coaguchek System, Model# 2032422 | Roche Diagnostics GmbH | GJS | Class II | |
| K021186 | Condomi Nature, Condomi Stimulation, Condomi Vanilla Gold, Condomi Supersafe, Condomi Xxl, Condomi Strong, | Condomi Erfert Prodoktionsgesellschaft mbH | HIS | Class II | |
| K021125 | Sensua! | Aac Consulting Group, Inc. | HIS | Class II | |
| K020934 | Dr. Japan Facil Point Spinal Needle | Myco Medical | BSP | Class II | |
| K020339 | Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser System | Dornier Medtech America, Inc. | GEX | Class II | |
| K023475 | Cns-9700 Series Central Nurse Station and Accessories | Nihon Kohden America Inc | MHX | Class II | |
| K023223 | Modification to Lumend Frontrunner Cto Catheter | Lumend, Inc. | DQY | Class II | |
| K023208 | Cedia Cyclosporine Plus Assay | Microgenics Corporation | MKW | Class II | |
| K023194 | Suresteppro/surestepflexx Professional Blood Glucose Management System | Lifescan, Inc. | CGA | Class II | |
| K023190 | E.cam Computer / E.soft Workstation | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K023182 | Indigo Optima Laser System, Optima Diffuser-Tip Fiberoptic-Bph, Optima Bare-Tip Fiberoptic,optima Laser Cart with Prints | Ethicon Endo-Surgery Inc | GEX | Class II | |
| K023158 | Randox Apolipoprotein Calibrator | Randox Laboratories, Limited | JIX | Class II | |
| K023058 | Qms Digoxin Reagent System on the Abbott Aeroset System | Seradyn, Inc. | KXT | Class II | |
| K022999 | Clearfil Ap-X Plt Intro Kit | Kuraray Medical, Inc. | EBF | Class II | |
| K022741 | Spot Pro (220V), Model 131.099 | Nucletron BV | MUJ | Class II | |
| K022540 | Cardio Id+(rz153+) | Rozinn Electronics, Inc. | DSH | Class II | |
| K022217 | Aeu-425 Transport II Portable Dental System | Aseptico, Inc. | EIA | Class I | |
| K021923 | Inratio Self-Test | Hemosense, Inc. | GJS | Class II | |
| K021693 | Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1 | Pan-America Hyperbarics, Inc. | CBF | Class II | |
| K021690 | Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-M3+1 | Pan-America Hyperbarics, Inc. | CBF | Class II | |
| K021689 | Pan-America Hyperbarics, Hyperbaric Chamber System, Model Pah-M10+2 | Pan-America Hyperbarics, Inc. | CBF | Class II | |
| K021595 | Gyrus ENT Nerve Stimulator | Gyrus Ent LLC | ETN | Class II | |
| K021250 | Mk-Dent Push Button Highspeed Handpiece, 4 Holes, Models Hs 2012 (Standard Head) & Hs 2014 (Small Head) | Handpiece Unlimited | EBF | Class II | |
| K020831 | Pt S Test Strips and Controls for the Coaguchek S System, Models 2032422 and 3271404 | Roche Diagnostics GmbH | GJS | Class II | |
| K023332 | Lightspeed Ultra Computed Tomography System with Wide-View | GE Healthcare | JAK | Class II | |
| K023202 | Microscan Synergies Plus | Dade Microscan, Inc. | JWY | Class II | |
| K020285 | Cma Cerebral Tissue Monitoring System | Cma Microdialysis AB | GWM | Class II | |
| K023287 | Drystar 5500 | Agfa Corp. | LMC | Class II | |
| K023227 | Usg 2000Sa | Ultraguide, Ltd. | HHJ | Class II | |
| K023055 | Bptru Portable Automated Non-Invasive Blood Pressure Monitor, Model Bpm-200 | Vsm Medtech, Ltd. | DXN | Class II | |
| K022881 | Cedara I-Softview | Cedara Software Corp. | LLZ | Class II | |
| K022737 | Hcmi X-Ray High Requency Chiropractic Radiographic | Health Care Mfg., Inc. | KPR | Class II | |
| K022667 | Hcmi X-Ray | Health Care Mfg., Inc. | KPR | Class II | |
| K022582 | Excalibur 9000 Totalsense Quad Head Array Coil | GE Healthcare Coils | MOS | Class II | |
| K022535 | Microtech Push Button Handpiece, Model Mhs-A100 | Microtech | EFB | Class I | |
| K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter and Hardhshell Venous/cardiotomy | Dideco S.p.A. | DTZ | Class II | |
| K022420 | Micrus Stretch-Resistant Microcoil System, Msr01 | Micrus Corp. | HCG | Class II | |
| K021608 | Smithwick Carotid Shunt | Implantable Devices | DXC | Class II | |
| K023245 | Blood Flow Analyzer (Bfa), Model 408-100-01 | Paradigm Medical Industries, Inc. | NJJ | Class II | |
| K022987 | Laxtex Examination Gloves, Powdered Contains 180 Mcgm or Less of Total Water Extractable Protein per Gram | Arista Latindo Industrial, Ltd. P.T. | LYY | Class I | |
| K022942 | Craniocut | Aesculap Inc | HBE | Class II | |
| K022913 | Nxstage Premixed Dialysate | NxStage Medical Inc | KPO | Class II | |
| K022907 | Anspach Powered Kerrison System (Pks) | The Anspach Effort, Inc. | HAD | Class II | |
| K022774 | Iq 200 System | Intl. Remote Imaging Systems | LKM | Class II | |
| K022391 | Modification to Kps-1, Kidney Perfusion Solutiion | Organ Recovery Systems, Inc. | KDN | Class II | |
| K021443 | 56 Series Jet Nebulizer | Project Marketing | CAF | Class II | |
| K020231 | Diasol-Additives | Diasol, Inc | KPO | Class II | |
| K023324 | Modification to Ebi Xfix Dfs System | Ebi, LLC | KTT | Class II | |
| K023318 | I-Flow Elastomeric Pump with Bolus | Halyard Health | MEB | Class II |