PYRAMES INC
FDA Regulatory Profile
PYRAMES INC has 1 FDA recall, 1 inspection, 1 510(k) clearance and 0 compliance actions on record.
What these totals cover: FDA records filed under the name "PYRAMES INC" and its spelling variant "Pyrames".
On this page: Recalls (1) · Inspections (1) · Facilities (1) · 510(k) clearances (1)
Latest recall Z-1508-2025 · Class II · Feb 24, 2025Latest inspection Dec 8, 2025 · NAI
Latest 510(k) Sep 29, 2023
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Summary
Record counts and when each FDA source was last refreshed
Records Count Last refreshed Source as of Status
Recalls 1 Nov 8, 2026 File dated Nov 3, 2026 Current 510(k) clearances 1 Nov 8, 2026 File dated Nov 2, 2026 Current Inspections 1 Nov 13, 2026 Newest record Nov 5, 2026 Current Compliance actions 0 Nov 2, 2026 Newest record Oct 29, 2026 Current
1 recall record on Feb 24, 2025.
Number Class Product Date
Z-1508-2025 Class II Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 Feb 24, 2025
1 inspection on Dec 8, 2025.
NAI No objectionable conditions or practices were found during the inspection.
VAI Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI Regulatory and/or administrative actions are recommended.
Look up the inspector observations behind these results with the FDA 483 search , or check for formal enforcement with the FDA warning letter search .
1 inspected site, newest inspection first.
Facility Location Inspections Latest
FEI 3014466900 Cupertino, CA 1 Dec 8, 2025
1 510(k) clearance on Sep 29, 2023.
K-Number Device Date
K223873 Boppli Infant Blood Pressure Monitor Sep 29, 2023
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