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 |
|---|---|---|---|---|---|
| K090829 | Pari Pep S | Pari Respiratory Equipment, Inc. | BWF | Class II | |
| K083594 | Ez Hsg Catheter.foamseal Catheter | Obg Products | LKF | Class II | |
| K091889 | Drx-Evolution, Model Vx3733-Sys | Eastman Kodak Company | KPR | Class II | |
| K091866 | Progeny Vantage Panoramic X-Ray System | Midmark Corp | MUH | Class II | |
| K091760 | Dermaport Ported Vascular Access System (Pvas) | Dermaport, Inc. | MSD | Class II | |
| K091444 | Perfscape | Olea Medical | LNH | Class II | |
| K091384 | Vinyl Powdered Examination Glove | Shun Tong Co., Ltd. | LYZ | Class I | |
| K090972 | Leksell Gammaplan | Elekta Instrument AB | MUJ | Class II | |
| K090838 | Stimulus/dissection Instruments | Axon Systems, Inc. | ETN | Class II | |
| K090599 | Md300k1 Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | DQA | Class II | |
| K083354 | Floraseal, Model Fs350d | Adhezion Biomedical, LLC | NZP | Class II | |
| K082982 | Breathe Technologies Ventilator and Accessories | Breathe Technologies, Inc. | ONZ | Class II | |
| K092013 | Syngo Volume Perfusion-CT Body | Siemens AG Medical Solutions | JAK | Class II | |
| K091804 | Cx50 Version 2.0 Diagnostic Ultrasound System and Transducers | Philips North America LLC | ITX | Class II | |
| K091617 | Qms Lidocaine Calibrators, Model 0374678 | Thermo Fisher Scientific Oy | DLJ | Class II | |
| K091558 | Biovision Digital Specimen Radiography System | Bioptics, Inc. | MWP | Class II | |
| K091536 | Optima Mr450w | GE Healthcare | LNH | Class II | |
| K091296 | Polytel Gma, Models Pwr-08-67, Pwr-08-07, Pwr-08-09 | Polymap Wireless | NBW | Class II | |
| K091024 | Chromid Mrsa Agar, Model: Ref 43 841 | bioMerieux, Inc. | JSO | Class II | |
| K090941 | Adhese One F | Ivoclar Vivadent, Inc. | KLE | Class II | |
| K090734 | Easyra Dldl Reagent, Calibrator; Easyqc Chemistry No Electrolytes, with Electrolytes | Medica Corp. | MRR | Class I | |
| K090587 | Starlight | Orthomerica Products, Inc. | OAN | Class II | |
| K092088 | Victory Xl 130 Four Wheel Scooter, Model Sc713 | Pride Mobility Products Corp | INI | Class II | |
| K091900 | Absorbatack 5Mm Single Use Absorbable Fixation Device | Covidien Lp, Formerly Registered AS United States | GDW | Class II | |
| K091179 | Monaco Rtp System, Vmat Option | Elekta Limited | MUJ | Class II | |
| K090955 | Smith & Nephew RF Cannulate | Smith & Nephew, Inc. | GXI | Class II | |
| K090914 | Axxent Balloon Applicator, Model Ab2034, Ab2045, Ab2056, Ab2057e, Ab2067e | Xoft, Inc. | JAD | Class II | |
| K090825 | Sq Is System | Neobiotech Co., Ltd. | DZE | Class II | |
| K083419 | Actherm Digital Clinical Thermometer Probe Covers, Model(s) Medaccu1010, Medaccu1010-1, Medaccu1020 | Actherm, Inc. | FLL | Class II | |
| K083183 | Aklarus Phototherapy System | Hill Laboratories | ILY | Class II | |
| K082849 | Silent Sleep | Craniofacial Pain Center of Idaho | LRK | Class II | |
| K091834 | Passport V Monitor, Model 0998-00-6100 | Datascope Corp., Patient Monitoring Division | MHX | Class II | |
| K091666 | Pascal Photocoagulator, Pascal-US | OptiMedica Corp. | GEX | Class II | |
| K091442 | Cd Horizon Spinal System | Medtronic Sofamor Danek | NKB | Class II | |
| K091156 | Trimed Sterile Product | Trimed Inc | HRS | Class II | |
| K091021 | Modification to Medicompass Connect | Imetrikus, Inc. | DRG | Class II | |
| K091008 | Stockert Centrifugal Pump Plus System (Scp Plus), Models 60-00-10, 60-00-55 | LivaNova Deutschland GmbH | DWA | Class II | |
| K090893 | Tigrt Tps | Linatech, LLC | MUJ | Class II | |
| K090707 | Talos Intervertebral Body Fusion Device | Meditech Advisors, LLC | MAX | Class II | |
| K090285 | Sonicaid Fm820 and Fm830 Encore | Huntleigh Healthcare Ltd. | HGM | Class II | |
| K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins | Treu-Instrumente GmbH | HWC | Class II | |
| K083903 | 3M Littmann Electronic Stethoscope, Model 3200 | 3M Company | DQD | Class II | |
| K091922 | Waterlase C100, Model 7100104 | Biolase MG LLC | GEX | Class II | |
| K091751 | Depuy Delta Xtend Reverse Shoulder Xlk Cup | Depuy Orthopaedics Inc. | KWS | Class II | |
| K091517 | Ralco, Model R225 Acs | Ralco S.r.l. | IZW | Class II | |
| K091274 | Coronis 5Mp Hd, Model Mdmg 5121 | Barco N.V. | LLZ | Class II | |
| K091180 | Minitape Urethral Sling | Mpathy Medical Devices, Ltd. | PAH | Class II | |
| K091088 | Ldr Spine Cervical Interbody Fusion System | Ldr Spine USA | ODP | Class II | |
| K091067 | 5.5 Polaris Spinal System | Highridge Medical, LLC | NKB | Class II | |
| K090952 | Zyfuse Facet Fixation System | Globus Medical, Inc. | MRW | Unclassified |