PYRAMES INC
FDA Regulatory Profile
PYRAMES INC appears in FDA public data with 1 recall, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1508-2025, Class II) was initiated on February 24, 2025. Its most recent 510(k) clearance was granted on September 29, 2023.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1508-2025 | Class II | Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 | February 24, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K223873 | Boppli Infant Blood Pressure Monitor | September 29, 2023 |