MRZ — Accessories, Pump, Infusion Class II
FDA product code MRZ covers "Accessories, Pump, Infusion", a Class II medical device regulated under 21 CFR 880.5725. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MRZ
- Device Class
- Class II
- Regulation Number
- 880.5725
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K230718 | gilero | UTC 3mL Medication Cartridge | June 15, 2023 |
| K220695 | elite biomedical solutions | Elite Biomedical Solutions Dose Request Cord | April 29, 2022 |
| K201634 | chengdu shifeng medical technology co | RG 3ml Medication Cartridge | March 26, 2021 |
| K193654 | welldoc | BlueStar Rx | April 7, 2020 |
| K191910 | b. braun melsugen | SpaceStation MRI | March 12, 2020 |
| K190013 | welldoc | WellDoc BlueStar | November 4, 2019 |
| K173531 | b.braun medical | Lockbox for Perfusor Space PCA Infusion Pump | August 2, 2018 |
| K171346 | icu medical | Sapphire Sets | August 25, 2017 |
| K162532 | welldoc | WellDoc BlueStar, WellDoc BlueStar Rx | January 12, 2017 |
| K160492 | hospira | Hospira Sapphire Sets | December 6, 2016 |
| K162225 | welldoc | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System | November 22, 2016 |
| K142374 | ivwatch | ivWatch Model 400 | February 13, 2015 |
| K142333 | american i.v. products, inc. dba aiv | SMART LABEL, PROPOFOL | December 18, 2014 |
| K141273 | welldoc | WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE | July 8, 2014 |
| K132618 | lifescan | ONETOUCH REVEAL | December 16, 2013 |
| K120209 | american i.v. products | PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE | April 12, 2012 |
| K120314 | welldoc | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | February 24, 2012 |
| K112370 | welldoc | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | October 14, 2011 |
| K101806 | aidera | AIDERA DIASEND SYSTEM | December 7, 2010 |
| K100066 | welldoc | DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 | July 15, 2010 |