FDA applicant

Spiracle Technology

Irvine, CA4 decisions1996–19980 recalls

FDA records 4 decisions for Spiracle Technology (Irvine, CA) from 1996 to 1998: 4 510(k) clearances. Most are in product codes CBP (Valve, Non-Rebreathing) and CAP (Monitor, Airway Pressure (Includes Gauge…). Its devices cite 1 predicate, 0 of them its own earlier devices. No 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Spiracle Technology since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Spiracle Technology by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Spiracle Technology

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?