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 |
|---|---|---|---|---|---|
| K021781 | Excelsior 3Ul Test Strips, for Use with the Home Diagnostics, Inc. Prestige Lx and Iq Blood Glucose Systems | Chay Medical, LLC | CGA | Class II | |
| K021493 | Andersen Nasogastric Tube with Stylet, Models an 11S, 13S, 14S & 18S | Andersen Products, Inc. | KNT | Class II | |
| K021355 | Endosseous Implant | Branemark Integration AB | DZE | Class II | |
| K021265 | Datex-Ohmeda Hmef 500 | GE Healthcare | CAH | Class II | |
| K021162 | Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-EU, Amax Destiny Coagulation Analyzer-Refurbished | Sigma Diagnostics, Inc. | JPA | Class II | |
| K021083 | Veracam | Lumalite, Inc. | EIA | Class I | |
| K020607 | Sleepflo, Model 101501 | Biomec, Inc. | MNR | Class II | |
| K022654 | Modification to Elecsys Ck-Mb Stat, Elecsys Ck-Mb | Roche Diagnostics GmbH | JHY | Class II | |
| K022569 | Prolite/plasmalite Mpx Pulsed Light System for Treatment of Vascular Lesions | Medical Bio Care Sweden AB | GEX | Class II | |
| K022568 | Prolite/plasmalite Mpx Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | GEX | Class II | |
| K022260 | Failsafe - Portable Infection Control Systems | Isolation Systems, Inc. | LGM | Class II | |
| K022206 | Jensen Gold Foil | Jensen Industries, Inc. | EJT | Class II | |
| K022063 | Safepro Safety Syringe | Formosa Medical Devices, Inc. | MEG | Class II | |
| K022032 | Acetal | Inovativ, LLC | EHP | Class I | |
| K022031 | Narkomed MRI-2 Anesthesia System, Model Nm-MRI-2 | Draeger, Inc. | BSZ | Class II | |
| K021988 | Medrad Continuum Mr Compatible Infusion System | Medrad, Inc. | FRN | Class II | |
| K021916 | Harmac Huber Needle Safety Device, H2984001 | Harmac Medical Products | FPA | Class II | |
| K021807 | Grass-Telefactor As40 Amplifier System | Grass Instrument Co. | OLV | Class II | |
| K021080 | Noncor Infusion Sets; Noncor Port Infusion Sets | Cardio Med Supplies, Inc. | FPA | Class II | |
| K020360 | Abr-2000 | Meridian AG | GZO | Class II | |
| K013756 | Alphacor; Alphacor-a (for Ahakic Eyes); Alphacor-P (for Phakic or Pseudophakic Eyes) | Argus Biomedical Pty, Ltd. | HQM | Class II | |
| K013197 | Ws-501 Heat Lamp | Lhasa Medical, Inc. | ILY | Class II | |
| K022790 | The Autotac System Titanium Tack | BioHorizons Implant Systems Inc | DZL | Class II | |
| K022764 | 7F Launcher Guide Catheter | Medtronic, Inc. | DQY | Class II | |
| K022718 | Vasoview 6 Harvesting Cannula, Models Vh-2000, Vh-2001 & Vh-2002 | Guidant Corporation, Cardiac Surgery | GEI | Class II | |
| K022556 | Reflection Modified Acetabular Shells | Smith & Nephew, Inc. | LPH | Class II | |
| K022547 | Acidified Tyrodes Solution | <Genx> Intl., Inc. | MQL | Class II | |
| K022443 | Spermassist | Nidacon International AB | MQL | Class II | |
| K022352 | Htf Plus with Hepes (Htf with Non-Essential Amino Acids) | <Genx> Intl., Inc. | MQL | Class II | |
| K022334 | Htf Plus - Htf with Non-Essential Amino Acids | <Genx> Intl., Inc. | MQL | Class II | |
| K022191 | Modification to Tenor Spinal System | Medtronic Sofamor Danek | KWP | Class II | |
| K022157 | RF Tent | Medtronic Navigation, Inc | LNH | Class II | |
| K022030 | Poly-Carb | Inovativ, LLC | EBG | Class II | |
| K021834 | Suture Fixation Device; Mesh Fixation Device | Mle, Inc. | GAW | Class II | |
| K021804 | Precision Plus Tuna Office System; Presision Tuna Office System; Provu Tuna System | Medtronic, Inc. | GEI | Class II | |
| K020785 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | FOZ | Class II | |
| K020550 | Passport 2 with View 12 ECG Analysis Module Model # 0998-00-0170-Xxxx | Datascope Corp. | DSI | Class II | |
| K020320 | Radiosystem/nt, Model 80-13020 | Styker Instruments | IYE | Class II | |
| K013869 | Sr Ivocron | Ivoclar Vivadent, Inc. | EBG | Class II | |
| K013003 | Aptimax Instrument Tray, Instrument Mat and Instrument Holder | Advanced Sterilization Products | FRG | Class II | |
| K022704 | Tailwind | Deltaglide | ITI | Class II | |
| K022623 | 5.0 Mm Diameter Polyaxial Screws (Moss Miami 6.35Mm System) | Depuyacromed | KWP | Class II | |
| K022550 | Coamatic Lr Antithrombin, Note: Lr=liquid Reagents | Instrumentation Laboratory Co. | JBQ | Class II | |
| K022510 | Fonix, Model 7000 | Frye Electronics, Inc. | ETW | Class II | |
| K022491 | Linical Hscrp Calibration Verifiers Levels a-E for Olympus Au Systems | Cliniqa Corporation | JJX | Class I | |
| K022290 | Protein S Ac | Siemens Healthcare Diagnostics Inc. | GGP | Class II | |
| K021760 | Navitrack System-Optical Tkr CT-Less, Model 900.120 | Orthosoft, Inc. | HAW | Class II | |
| K021759 | 14F X 55Cm Ultra-Flow Catheter, Models Ufs55, Uft55 | Medcomp | MSD | Class II | |
| K021398 | Apl Iga Elisa Kit | Louisville Apl Diagnostics Inc | MID | Class II | |
| K020057 | Palmlight | Cao Group, Inc. | EBZ | Class II |