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 |
|---|---|---|---|---|---|
| K011353 | Acon Opi One Step Opiates Test Strip, Acon Opi One Step Opiates Test Device | Acon Laboratories, Inc. | DJG | Class II | |
| K011054 | Rads | Chason Healthcare, LLC | DIO | Class II | |
| K011052 | Osteomark Ntx Point of Care Prescription Home Use | Ostex Intl., Inc. | JMM | Class I | |
| K010734 | Branan Medical Corperation Monitect Tca Drug Screen Test, Model Mc21 and Md21 | Branan Medical Corp. | MLK | Class II | |
| K990667 | Kls-Martin Temporary Condylar Implant | KLS-Martin L.P. | NEI | Class II | |
| K012060 | Modification To:hu-Friedy Brand Satin Swivel Ultrasonic Insert | HU-Friedy Mfg. Co. LLC | ELC | Class II | |
| K012035 | Braun Precision Sensor Pro, Model Bp 2590 | Braun GmbH | DXN | Class II | |
| K012028 | Alliger Ultrasonic Surgical System Model Auss-5 | Misonix, LLC | LFL | Unclassified | |
| K011914 | Hydro2, Hs-75 | Innovision, Inc. | HQD | Class II | |
| K011335 | Synths One-Third Tubular Dcl Plate | Synthes (USA) Products LLC | HRS | Class II | |
| K011334 | Synthes Curved Reconstruction Plate | Synthes (USA) Products LLC | HRS | Class II | |
| K011140 | Quanta Plex Ena Profile 4 | Inova Diagnostics, Inc. | LLL | Class II | |
| K010159 | Dried Gram-Negative and Gram-Positive Mic/combo Panels | Dade Microscan, Inc. | LTT | Class II | |
| K002874 | Well-TENS | Well-Life Consultant | GZJ | Class II | |
| K002336 | Ms104a, Newmini II (Ems-II), Model Ap-101050T and Medtrim (Ems-V), Model Ap-102050T | Apex Medical, Inc. | IPF | Class II | |
| K012191 | Teratech Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes | Teratech Corp. | IYN | Class II | |
| K012095 | The Lps - Continuum Tm Hybrid Tibia, Models 32-5886-2Y-Xx (Zimmer) and 05-119-Xxyy1-0 (Implex) | Implex Corp. | JWH | Class II | |
| K012031 | Modification to Thermal Angel | Estill Medical Technologies, Inc | BSB | Class II | |
| K012002 | Viking Optima Guiding Catheter | Boston Scientific Corporation | DQY | Class II | |
| K011998 | Metronic Sofamor Danek Cement Restrictor | Medtronic Sofamor Danek | JDK | Class II | |
| K011332 | RF-IVD Wireless Dosimeter-Model 1133 | Sun Nuclear Corporation | IYE | Class II | |
| K011135 | Gsi Audera | Nicolet Biomedical, Inc. | EWO | Class II | |
| K012159 | Rapid Drug Screen | American Bio Medica Corp. | DKZ | Class II | |
| K012024 | Ebi Xfix Dfs System | Ebi, LLC | KTT | Class II | |
| K011968 | Streerable Ptca Guidewire | Lake Region Mfg., Inc. | DQX | Class II | |
| K011869 | Xenf-Dp Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | Olympus Optical Co., Ltd. | EOB | Class II | |
| K011780 | K-Assay C1-Ina | Kamiya Biomedical Company, LLC | DBA | Class II | |
| K011718 | Bausch & Lomb Soflens One Day Disposable (Hilafilcon a) Visibility Tinted Contact | Bausch & Lomb Incorporated | MVN | Class II | |
| K011692 | Homogeneous Enzymic Homocysteine Reagent | Intersect Systems, Inc. | LPS | Class II | |
| K011689 | Homogeneous Enzymic Homocysteine Reagent | Catch, Inc. | LPS | Class II | |
| K011325 | Medifix Ureteroscope | Medifix, Inc. | FGB | Class II | |
| K010337 | Lipoprint System, Ldl Subfractions | Quantimetrix Corp. | JHO | Class I | |
| K010270 | Tremorometer | Flexable Systems, Inc. | GYD | Class II | |
| K010006 | Drainage Catheter or Foley Catheter | Applied Medical Resources Corp | EZL | Class II | |
| K003949 | Tacker, Model R65-933 | A & A Medical, Inc. | OCW | Class II | |
| K001508 | Laserskin Dressing | Fidia Advanced Biopolymers SRL | MGP | Unclassified | |
| K012171 | Modification to: Argus System-Continuous Expert Care Network W/smart Alrams | Visicu, Inc. | MSX | Class II | |
| K012034 | Modification to: Sipap Infant Nasal CPAP Circuit | Sensor Medics Corp. | BZD | Class II | |
| K012005 | Modification to Alarmview Wireless Data Network System | Data Critical Corp. | MSX | Class II | |
| K011999 | Modification to Flexview Clinical Monitoring System | Data Critical Corp. | MSX | Class II | |
| K011281 | Intuitive Surgical Ultrasonic Shears | Intuitive Surgical, Inc. | NAY | Class II | |
| K011207 | Laser Peripherals Reusable Holmium Fiber | Laser Peripherals LLC | GEX | Class II | |
| K010400 | Vacuum Assisted Core Biopsy Device | Promex, Inc. | KNW | Class II | |
| K012207 | Advantage Nasal Mask, Small, Advantage Nasal Mask. Regular, Models Tms-2520, Tms 2530 | Tiara Medical Systems, Inc. | BZD | Class II | |
| K012178 | Fresenius C.a.t.s; Ati Autotransfusion Set; Psq Plasma Sequestration Set; Psq-Dd Plasma Sequestration Direct Draw | Fresenius Hemotechnology, Inc. | CAC | Class II | |
| K011830 | Tri-Fix Spinal Fixation System | Endius, Inc. | KWP | Class II | |
| K011520 | Restore-X | First Scientific Limited | EMA | Class II | |
| K011453 | Tooth Shade Resin Material | Rite-Dent Manufacturing Corp. | EBF | Class II | |
| K011438 | Bilateral Fitting of the Branemark Bone-Anchored Hearing Aid (Baha) System. | Entific Medical Systems, Inc. | LXB | Class II | |
| K010415 | Isodan | Specialites Septodont | KLE | Class II |