Data / Medical devices / United States / Pyrames Inc
Pyrames Inc: FDA-registered device maker in Cupertino, CA, United States, 1 510(k) clearance
Pyrames Inc is registered with the FDA (registration 3014466900) in Cupertino, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 29, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014466900
- Address
- 21730 Stevens Creek Blvd Suite 201A, Cupertino, CA, United States, 95014
- Owner or operator
- PyrAmes Inc (10088807)
- Roles
- Manufacturer
- First device listed
- October 12, 2023
- Registered through
- 2026
- Brand names listed
- Boppli
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 29, 2023 | K223873 | Boppli Infant Blood Pressure Monitor | DXN | Substantially Equivalent | Pyrames, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 24, 2025 | 96414 | Class II | Ongoing | 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. | accessdata.fda.gov |
Compare with other makers
Updated April 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.