Spark Biomedical Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2287-2025Class IISparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-32July 2, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K251246Sparrow AscentAugust 25, 2025
K230796Sparrow AscentJune 20, 2023
K201873Sparrow Therapy SystemJanuary 2, 2021