Spark Biomedical Inc

FDA Regulatory Profile

Spark Biomedical Inc appears in FDA public data with 1 recall, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2287-2025, Class II) was initiated on July 2, 2025. Its most recent 510(k) clearance was granted on August 25, 2025.

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