FDA product code MRZ: Accessories, Pump, Infusion
MRZ is the FDA product code for accessories, pump, infusion. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel. FDA has cleared 48 510(k) submissions under MRZ, 2 in the last five years, from 29 different applicants. The average 510(k) review took 131 days (median 90). FDA has posted 8 recalls for MRZ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Accessories, Pump, Infusion |
| Device class | Class II |
| Regulation | 21 CFR 880.5725 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for MRZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 117 |
| 2018 | 1 | 260 |
| 2019 | 1 | 305 |
| 2020 | 2 | 169 |
| 2021 | 1 | 283 |
| 2022 | 1 | 51 |
| 2023 | 1 | 92 |
Compare with all 510(k) review times · Search every MRZ clearance
Top MRZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Welldoc, Inc. | 8 | 2020-04-07 |
| Alexander Mfg. Co. | 8 | 1997-10-20 |
| Smiths Medical MD, Inc. | 3 | 2009-06-12 |
| National Custom Ent., Inc. | 3 | 2001-09-12 |
| Aidera AB | 2 | 2010-12-07 |
24 more applicants have MRZ clearances. See the full list in Caduvo.
Most recent MRZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230718 | Gilero, LLC | UTC 3mL Medication Cartridge | 2023-06-15 | 92 |
| K220695 | Elite Biomedical Solutions | Elite Biomedical Solutions Dose Request Cord | 2022-04-29 | 51 |
| K201634 | Chengdu Shifeng Medical Technology Co., Ltd. | RG 3ml Medication Cartridge | 2021-03-26 | 283 |
| K193654 | Welldoc, Inc. | BlueStar Rx | 2020-04-07 | 99 |
| K191910 | B. Braun Melsugen AG | SpaceStation MRI | 2020-03-12 | 239 |
Recalls for MRZ devices
8 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-12-19.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 5 |
| 2023 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- A4220 — Refill kit for implantable infusion pump
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement
- E0783 — Infusion pump system, implantable, programmable (includes all components, e.g., pump, catheter, connectors, etc.)
Frequently asked questions
What is FDA product code MRZ?
MRZ is the FDA product code for accessories, pump, infusion. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel.
What device class is MRZ?
Class II, regulation 21 CFR 880.5725. Typical premarket route: 510(k).
How long does a 510(k) take for product code MRZ?
Across 48 cleared submissions the average was 131 days from receipt to decision (median 90).
Which companies have the most MRZ clearances?
Welldoc, Inc. (8); Alexander Mfg. Co. (8); Smiths Medical MD, Inc. (3); National Custom Ent., Inc. (3); Aidera AB (2).
Have MRZ devices been recalled?
Yes: 8 product recalls across 4 recall events; the most recent began 2023-12-19.
Next steps
- Run an FDA pathway report with predicate devices for product code MRZ
- Run a recall and safety report across every MRZ manufacturer
- Watch product code MRZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times