FDA applicant

Airxpanders, Inc.

Palo Alto, CA3 decisions2016–20190 recalls

FDA records 3 decisions for Airxpanders, Inc. (Palo Alto, CA) from 2016 to 2019: 2 510(k) clearances and 1 De Novo grant. All are in product code PQN (Carbon Dioxide Gas Controlled Tissue Expander). Its devices cite 2 predicates, 2 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 and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2019

2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Airxpanders, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Airxpanders, 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

Airxpanders, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?