FDA applicant

Caire, Inc.

Ball Ground, GA7 decisions1995–20251 recall

FDA records 7 decisions for Caire, Inc. (Ball Ground, GA) from 1995 to 2025: 7 510(k) clearances. Most are in product codes CAW (Generator, Oxygen, Portable) and BYJ (Unit, Liquid-Oxygen, Portable). Its devices cite 8 predicates, 2 of them its own earlier devices. 1 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 Caire, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Caire, 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

Other applicant names beginning “Caire”

FDA records each applicant name separately; these may or may not be the same firm.

Caire Diagnostics, Inc. 1

Caire, 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?

What has been recalled?

Other applicant names beginning “Caire”