FDA product code QBV: Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
QBV is the FDA product code for centrifuge for preparation of cell concentrate and/or plasma concentrate. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under QBV, 2 in the last five years. The average 510(k) review took 405 days (median 405); 405 days on average over the last three years.
Definition
To prepare cell concentrate and/or plasma concentrate by separating cells through centrifugation. Contraindications - Labeling Warnings and Precautions: The safety and effectiveness of this device for in vivo indications for use has not been established.
Classification
| Field | Value |
|---|---|
| Device name | Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate |
| Device class | Class I |
| Regulation | 21 CFR 862.2050 |
| Review panel | HE — Hematology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for QBV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 2 | 405 |
Compare with all 510(k) review times · Search every QBV clearance
Top QBV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Miracell Co., Ltd. | 2 | 2026-04-02 |
Most recent QBV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250518 | Miracell Co., Ltd. | SMART M-CELL Bone Marrow Concentration System | 2026-04-02 | 405 |
| K250516 | Miracell Co., Ltd. | SMART M-CELL PRP Concentration System | 2026-04-02 | 405 |
Recalls for QBV devices
openFDA lists no recalls for product code QBV.
Frequently asked questions
What is FDA product code QBV?
QBV is the FDA product code for centrifuge for preparation of cell concentrate and/or plasma concentrate. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Hematology panel.
What device class is QBV?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code QBV?
Across 2 cleared submissions the average was 405 days from receipt to decision (median 405).
Which companies have the most QBV clearances?
Miracell Co., Ltd. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QBV
- Run a recall and safety report across every QBV manufacturer
- Watch product code QBV 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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