FDA applicant

Kalila Medical, Inc.

Campbell, CA3 decisions2014–20172 recalls

FDA records 3 decisions for Kalila Medical, Inc. (Campbell, CA) from 2014 to 2017: 3 510(k) clearances. All are in product code DYB (Introducer, Catheter). Its devices cite 4 predicates, 2 of them its own earlier devices. 2 recalls are 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 Kalila Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2014high 2 (2017) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

2in 2017

2014high 2 (2017) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Kalila Medical, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Kalila Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?