MRZClass II
Accessories, Pump, Infusion
21 CFR 880.5725 / General Hospital
MRZ is the FDA product code for Accessories, Pump, Infusion, a class II device type, regulated under 21 CFR 880.5725. As of , FDA records hold 48 510(k) clearances under this code, the most recent dated , and 8 recalls.
Classification record
- Product code
- MRZ
- Device name
- Accessories, Pump, Infusion
- Regulation
- 21 CFR 880.5725
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 48
- Ingested recalls
- 8
Clearances, product code MRZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1997 | 9 |
| 1998 | 3 |
| 1999 | 1 |
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 2 |
| 2005 | 1 |
| 2007 | 2 |
| 2008 | 4 |
| 2009 | 2 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
Applicants with the most clearances
Product code MRZ| Applicant | Clearances |
|---|---|
| Alexander Mfg. Co. | 8 |
| Welldoc | 8 |
| Abbott Medical | 5 |
| National Custom Ent., Inc. | 3 |
| Aidera AB | 2 |
| American I.V. Products, Inc. | 1 |
| American I.V. Products, Inc. dba Aiv, Inc. | 1 |
| Animas Corp. | 1 |
| Appro Healthcare, Inc. | 1 |
| B. Braun Melsugen AG | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
