FDA applicant

Calibra Medical, Inc.

Redwood City, CA3 decisions2010–20120 recalls

FDA records 3 decisions for Calibra Medical, Inc. (Redwood City, CA) from 2010 to 2012: 3 510(k) clearances. All are in product code OPP (Pump, Infusion, Insulin Bolus). Its devices cite 5 predicates, 3 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2012

2010high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Calibra Medical, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Calibra Medical, 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

Calibra Medical, Inc.

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?