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 |
|---|---|---|---|---|---|
| K012235 | Denver Pleural Effusion Shunt and Denver Pleural Effusion Shunt with External Pump Chamber | Denver Biomedical, Inc. | KPM | Class II | |
| K012142 | The Quiet Sleeper | Precision Dental Laboratories, Inc. | LRK | Class II | |
| K012127 | Pulsemaster Erbium Dental Laser System | American Dental Technologies, Inc. | GEX | Class II | |
| K010804 | Megabeam/ceralas Reuseable Handpiece and Disposable Tips | Biolitec, Inc. | GEX | Class II | |
| K010715 | Al-40 | DDC Technologies, Inc. | GEX | Class II | |
| K010396 | C. Net 2100 | Cardionetics, Ltd. | MLO | Class II | |
| K004001 | Monolyth Mimesys Hollow Fiber Oxygenator | Dideco S.p.A. | DTZ | Class II | |
| K002839 | End Expiratory Filter, Model Rt020 | Fisher & Paykel Healthcare, Inc. | CAH | Class II | |
| K994105 | Hemo-Flow Double Lumen Catheter, Models Hfs-24, Hfs-28, Hfs-32, Hfs-36, Hfs-40 | Medical Components, Inc. | MSD | Class II | |
| K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | HAW | Class II | |
| K013009 | Belleglass Hp Dc Opaceous Dentin Lcte 2 | Sybron Dental Specialties, Inc. | EBF | Class II | |
| K013002 | Triage Tox Drug Screen Calibration Verification Controls, Catalog #94002 | Biosite Incorporated | DIF | Class I | |
| K012999 | Triage Tox Drug Screen Controls, Catalog #94001 | Biosite Incorporated | DIF | Class I | |
| K012992 | Masimo Set Radical Pulse Oximeter with Satshare and Masimo Series of Sensors and Cables | Masimo Corporation | DQA | Class II | |
| K012986 | Bipolar Irrigation Forceps | Aesculap Inc | GEI | Class II | |
| K012948 | Modification to Vaxcel Dialysis Catheter | Boston Scientific/Medi-Tech | MSD | Class II | |
| K012592 | Easytravel | Tzora Active Systems, Ltd. | INI | Class II | |
| K012474 | Atac Pak Cpk Reagent Kit | Elan Holdings, Inc. | CGS | Class II | |
| K012446 | Office Based Anesthesia Machine MRI, Model Oba-1 MRI | Charles A. Smith | BSZ | Class II | |
| K012345 | New Heights Electric Elevating Manual Wheelchair | Bromac Assistive Technology | IPL | Class II | |
| K012336 | Modification To:escort Vision Central Station Telemetry System, Model 20500 | Medical Data Electronics | DSI | Class II | |
| K012126 | The Salicept Oral Patch | Carrington Laboratories, Inc. | OLR | Unclassified | |
| K012091 | Pro-Femur | Wrightmedicaltechnologyinc | LZO | Class II | |
| K010306 | Medcomp Excell Split Tip Catheter | Medcomp | MSD | Class II | |
| K013104 | Simplicity Qd Soft Infusion Set for Use by People with Diabetes in Infuse Insulin Subcutaneously from a Pump or Syringe | Sterling Medivations, Inc. | FPA | Class II | |
| K013008 | Nexus 2 Modified | Sybron Dental Specialties, Inc. | EMA | Class II | |
| K012982 | Cooltouch Varizoom | New Star Lasers, Inc. | GEX | Class II | |
| K012952 | Hemashield Gold Woven Double Velour Vascular Graft - Branch Graft | Boston Scientific/Medi-Tech | DSY | Class II | |
| K012947 | Smartflow | Florence Medical, Ltd. | DQK | Class II | |
| K012946 | Sunliteled Model #2810 | Kinetic Instruments, Inc. | EBZ | Class II | |
| K012435 | Entry Site Alignment System Model # Cx9626 | Bausch & Lomb Incorporated | NGY | Class I | |
| K012383 | Gemini Pc-1,Pc-2, Pc-2Tx,pc-4, Signature Edition Infusion Pump (Se), Medsystem III Infusion (Msiii), Medsystem Patient C | CareFusion 303, Inc | FRN | Class II | |
| K013111 | Exhale Probe | Broncus Technologies, Inc. | EOQ | Class II | |
| K013007 | Belleglass Hp Enamel 2 | Sybron Dental Specialties, Inc. | EBF | Class II | |
| K012914 | Sonicwave Sonic Plaque Remover | FKA Distributing Co., LLC | JEQ | Class I | |
| K012876 | Dermagrip Powder Free Latex Examination Gloves with Aloe Vera Protein Content Labeling Claim (50 Micrograms or Less) | Wrp Specialty Products Sdn. Bhd. | LYY | Class I | |
| K012786 | Powderfree Nitrile Neoprene Examination Gloves (Pulple) | Shamrock Manufacturing Company | LZA | Class I | |
| K012772 | Cts-485 Ultrasound Imaging System | Shantou Institute of Ultrasonic Instuments | IYO | Class II | |
| K012709 | Powder-Free Latex Examination Gloves with Aloe Vera and Protein Content Labeling Claim (50 Micrograms or Less) (Green) | Qingdao Bestex Rubber & Plastic Products Co., Ltd | LYY | Class I | |
| K012466 | Bis/eeg Module | General Electric Medical Systems Information Techn | OLW | Class II | |
| K012366 | Navigus II Trajectory Guide | Image-Guided Neurologics, Inc. | HAW | Class II | |
| K012340 | Bayer Advia System; Unsaturated Iron Binding Capacity (Uibc) | Bayer Corp. | JMO | Class I | |
| K012335 | Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide Plus 30 Solutions | Sybron Dental Specialties, Inc. | JOJ | Class II | |
| K012283 | Sologard Locking Plus Syringe with Needle | Safegard Medical Products, Inc. | FMI | Class II | |
| K012238 | Doseright | Philips North America LLC | JAK | Class II | |
| K012227 | Mucheck - Monitor Unit Validation Program, Model V4.1 | Oncology Data Systems, Inc. | IYE | Class II | |
| K012176 | Ultracision Harmonic Scalpel Blades with Protective Sleeve, Models Dh105, Dh145, Sh105, Sh145 | Ethicon Endo-Surgery Inc | LFL | Unclassified | |
| K012144 | Cytoflex | Unicare Biomedical, Inc. | LYC | Class II | |
| K012081 | Dynamic Compression Shape Memory Alloy (Sma) Staple System | Medtronic Sofamor Danek | JDR | Class II | |
| K011794 | Xltek LED Goggles, Model LED-01 | Excel Tech., Ltd. | GWE | Class II |