FDA applicant

Spica, Inc.

Mchenry, IL3 decisions1978–19800 recalls

FDA records 3 decisions for Spica, Inc. (Mchenry, IL) from 1978 to 1980: 3 510(k) clearances. Most are in product codes BSZ (Gas-Machine, Anesthesia) and CAN (Regulator, Pressure, Gas Cylinder). 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 Spica, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spica, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Spica, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Spica, Inc.

Which product codes does it file in?

What has FDA decided for it lately?