Pyrames Inc

Cupertino, CA, US

PYRAMES INC appears in FDA device records in Cupertino, CA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 1 510(k) clearance for Pyrames Inc in 2023.

Clearances by year, as a table

510(k) clearance decisions for Pyrames Inc, by decision year
Year	Clearances
2023	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K223873	Boppli Infant Blood Pressure Monitor	DXN	Substantially Equivalent	2023-09-29

Registered establishments

FDA registered establishments for Pyrames Inc, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3014466900	3014466900	PYRAMES INC	21730 Stevens Creek Blvd, Cupertino, CA 95014 US	2026	DXN

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1508-2025	Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007	Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. Containment actions: 1) Ventilator lines not to touch the isolette (e.g. mattress, side rails, pillow) or patient, 2) Move affected monitor to patient's foot.	Class II	2025-02-24	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain