SMART M-CELL PRP Concentration System
FDA 510(k) clearance K250516 · decided 2026-04-02
Clearance details
- K-number
- K250516
- Device name
- SMART M-CELL PRP Concentration System
- Applicant
- Miracell Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-02-21
- Decision date
- 2026-04-02
- Days to decision
- 405 days
- Clearance type
- Traditional
- Product code
- QBV
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Miracell Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SMART M-CELL Bone Marrow Concentration System (K250518) | Miracell Co., Ltd. | 2026-04-02 |
Recalls involving this device
No recalls on record reference this clearance.