# MRZ: Accessories, Pump, Infusion

- Device class: 2; regulation: 21 CFR 880.5725; FDA's rule: 510(k) required
- FDA decisions: 48
- 510(k) review time 2021–2025: median 92 days (middle half 72–188)
- Recalls: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2014: 2
- 2015: 1
- 2016: 2
- 2017: 2
- 2018: 1
- 2019: 1
- 2020: 2
- 2021: 1
- 2022: 1
- 2023: 1

## Most-cited predicates
- K100066: Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1 (2010), cited by 3
- K193654: BlueStar Rx (2020), cited by 2
- K101806: Aidera Diasend System (2010), cited by 2
- K051079: Hospira Gemstar Infusion Pump System with Hospira Gemstar Spring Assist Mechanism Lockbox-7 Therapy (2005), cited by 2
- K070438: Medtronic Minimed Carelink Usb Connector, Model NMT 7305 (2007), cited by 1
- K961486: Ivac Medsystem Iii, Infusion Pump W/Drug Editing Software Kit (1998), cited by 1
- K082783: Cadd -Solis Medication Safety Software:  Administrator and Point-of-Care (2008), cited by 1
- K162532: WellDoc BlueStar, WellDoc BlueStar Rx (2017), cited by 1
- K080227: Accu-Chek 360 Diabetes Management System (2008), cited by 1
- K190013: WellDoc BlueStar (2019), cited by 1

Source page: https://510kreport.com/product-code/MRZ
Data by year (CSV): https://510kreport.com/product-code/MRZ.csv