DeviceClearance

Product code QBV— Clinical Chemistry

SMART M-CELL Bone Marrow Concentration System

Classification name
Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
Device class
Class 1
Regulation
21 CFR 862.2050
Advisory panel
Clinical Chemistry
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QBV under 21 CFR 862.2050, via openFDA

Market context for product code QBV

FDA has cleared 2 devices under product code QBV, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code QBV

Recent clearances under product code QBV

Data sourced from openFDA. This site is unofficial and independent of the FDA.