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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K200818 | 3DMax MID Anatomical Mesh | C.R. Bard Inc | FTL | Class II | |
| K200680 | Synvitro Hyadase | Origio A/S, A Coopersurgical Company | MQL | Class II | |
| K200542 | Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head | Olympus Medical Systems Corp. | OWN | Class II | |
| K200498 | SCENARIA View | FUJIFILM Healthcare Americas Corporation | JAK | Class II | |
| K200063 | AeroEclipse* ONE BAN | Trudell Medical International | CAF | Class II | |
| K193526 | Syringe with safety needle, Safety needle | Jiangsu Caina Medical Co., Ltd | FMF | Class II | |
| K193204 | Cryocheck Chromogenic Factor VIII | Precision BioLogic Inc. | GGP | Class II | |
| K192793 | Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I | Olympus Medical Systems Corp. | FDF | Class II | |
| K201676 | Barricaid Instrument Tray | Intrinsic Therapeutics, Inc. | QHG | Class II | |
| K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | Lumenis Ltd | GEX | Class II | |
| K201662 | REDUCT® Headless Compression Screw System | Skeletal Dynamics, Inc | HWC | Class II | |
| K201660 | KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | Kyocera Medical Technologies, Inc. | OQG | Class II | |
| K201272 | Geneva | Nucletron BV | JAQ | Class II | |
| K200905 | HealthMammo | Zebra Medical Vision, Ltd. | QFM | Class II | |
| K200655 | FibroScan® 630 | Echosens | IYO | Class II | |
| K200578 | Infrared Thermometer Model Number RN-50A,RN-50B | Ningbo Ranor Medical Science & Technology Co., Ltd. | FLL | Class II | |
| K200497 | Vivid S60N, Vivid S70N | GE Healthcare | IYN | Class II | |
| K193456 | Arm Blood Pressure Monitor | Ningbo Ranor Medical Science & Technology Co., Ltd. | DXN | Class II | |
| K192386 | KeraStat Cream | Keranetics, Inc. | KGN | Unclassified | |
| K191698 | TiN Coated Humeral Head | Fx Shoulder USA, Inc. | KWT | Class II | |
| K191449 | ZCA All-Poly Acetabular Cups | Zimmer GmbH | JDI | Class II | |
| K201621 | Magicore II System | Innobiosurg Co., Ltd. | NHA | Class II | |
| K201618 | Nalu Neurostimulation SCS system | Boston Scientific Neuromodulation Corporation | GZB | Class II | |
| K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | Innovasis, Inc | MAX | Class II | |
| K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage | Eit Emerging Implant Technologies GmbH | MAX | Class II | |
| K201234 | BD SoloShot Mini Syringe/ BD Auto Disable Syringe | Becton Dickinson & Co | FMF | Class II | |
| K201149 | CoLink Plating System | In2bones USA, LLC | HRS | Class II | |
| K201109 | CO2 Laser Therapy System | Shanghai Apolo Medical Technology Co.,Ltd. | GEX | Class II | |
| K201080 | Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens | Visco Vision Inc. | LPL | Class II | |
| K201064 | V30 System, V20 System, V10 System, V-FR Handpiece | Viora, Ltd. | PBX | Class II | |
| K201018 | Encision AEM enTouch 2X Scissor | Encision, Inc. | GEI | Class II | |
| K201005 | FullFocus | Paige.ai, Inc | QKQ | Class II | |
| K200690 | LifeSignals ECG Remote Monitoring Patch Platform | LifeSignals, Inc. | DRG | Class II | |
| K200531 | iHealth Infrared No-Touch Forehead Thermometer | Andon Health Co., Ltd | FLL | Class II | |
| K191146 | Humelock TiN Coated Glenosphere | Fx Shoulder USA, Inc. | PHX | Class II | |
| K200325 | Orbit Subretinal Delivery System | Orbit Biomedical | FMF | Class II | |
| K193515 | Mako Total Knee Application | Mako Surgical Corp. | OLO | Class II | |
| K193097 | Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | |
| K193063 | EMBOTRAP III Revascularization Device | Neuravi Limited | NRY | Class II | |
| K201338 | Allograft MIS Delivery System | LifeNet Health | FMF | Class II | |
| K201276 | ExacTrac Dynamic | Brainlab, Inc. | IYE | Class II | |
| K201042 | Probeat-Cr | Hitachi, Ltd. | LHN | Class II | |
| K201000 | Biodesign Staple Line Reinforcement | Cook Biotech Incorporated | FTM | Class II | |
| K200960 | Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) | Medline Industires, Inc. | LZA | Class I | |
| K200218 | Digiscan FDX | Allengers Medical Systems Limited | OWB | Class II | |
| K192561 | Traus Sus20 | Saeshin Precision Co., Ltd. | DZI | Class II | |
| K193628 | AGE Automatic Wrist Blood Pressure Monitor | Dongguan e-Test Technology Co.,Ltd | DXN | Class II | |
| K193627 | Automatic Upper Arm Blood Pressure Monitor | Dongguan e-Test Technology Co.,Ltd | DXN | Class II | |
| K201725 | DigitalDiagnost C50 | Philips Healthcare (Suzhou) Co., Lit. | KPR | Class II | |
| K201607 | Eclipse Treatment Planning System v16.1 | Varian Medical Systems, Inc. | MUJ | Class II |