FDA applicant

Oxlife, Inc.

Hendersonville, NC5 decisions1994–20080 recalls

FDA records 5 decisions for Oxlife, Inc. (Hendersonville, NC) from 1994 to 2008: 5 510(k) clearances. All are in product code CAW (Generator, Oxygen, Portable). Its devices cite 5 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Oxlife, LLC”.

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 Oxlife, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Oxlife, 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?