FDA product code BRZ: Set, Blood Transfusion
BRZ is the FDA product code for set, blood transfusion. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel. FDA has cleared 30 510(k) submissions under BRZ, 1 in the last five years, from 27 different applicants. The average 510(k) review took 102 days (median 78). FDA has posted 24 recalls for BRZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Set, Blood Transfusion |
| Device class | Class II |
| Regulation | 21 CFR 880.5440 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BRZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 125 |
| 2022 | 1 | 262 |
Compare with all 510(k) review times · Search every BRZ clearance
Top BRZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baxter Healthcare Corporation | 2 | 2022-11-17 |
| Puritas Health Care, Inc. | 2 | 1994-04-21 |
| The Boston Medical Group | 2 | 1982-09-30 |
| Arteriocyte Medical Systems, Inc. | 1 | 2013-10-04 |
| Shan Dong Wei Gao Group Medical Polymer Products | 1 | 2009-04-10 |
22 more applicants have BRZ clearances. See the full list in Caduvo.
Most recent BRZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220558 | Baxter Healthcare Corporation | Blood Administration Sets | 2022-11-17 | 262 |
| K210335 | Baxter Healthcare Corporation | Blood Administration Set | 2021-06-10 | 125 |
| K132905 | Arteriocyte Medical Systems, Inc. | 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER | 2013-10-04 | 18 |
| K083349 | Shan Dong Wei Gao Group Medical Polymer Products | BLOOD TRANSFUSION SET | 2009-04-10 | 148 |
| K073339 | Fenwal, Inc. | BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR | 2008-03-03 | 96 |
Recalls for BRZ devices
24 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-07-17.
Frequently asked questions
What is FDA product code BRZ?
BRZ is the FDA product code for set, blood transfusion. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel.
What device class is BRZ?
Class II, regulation 21 CFR 880.5440. Typical premarket route: 510(k).
How long does a 510(k) take for product code BRZ?
Across 30 cleared submissions the average was 102 days from receipt to decision (median 78).
Which companies have the most BRZ clearances?
Baxter Healthcare Corporation (2); Puritas Health Care, Inc. (2); The Boston Medical Group (2); Arteriocyte Medical Systems, Inc. (1); Shan Dong Wei Gao Group Medical Polymer Products (1).
Have BRZ devices been recalled?
Yes: 24 product recalls across 5 recall events; the most recent began 2014-07-17.
Next steps
- Run an FDA pathway report with predicate devices for product code BRZ
- Run a recall and safety report across every BRZ manufacturer
- Watch product code BRZ 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.
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