510(k) Report

FDA applicant

Pyrames, Inc.

Cupertino, CA1 decision2023–20231 recall

FDA records 1 decision for Pyrames, Inc. (Cupertino, CA) in 2023: 1 510(k) clearance. All are in product code DXN (System, Measurement, Blood-Pressure…). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Pyrames, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2023high 1 (2025) · low 0 (2023)2026

Class I Class II/III not classified

FIG. 1 — Pyrames, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K223873Boppli Infant Blood Pressure MonitorPyrames, Inc. · 20231 recall

The one decision as Pyrames, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K223873Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007Feb 24, 2025Class II