510(k) Report

FDA applicant

Ceiba Healthcare US, Inc.

New York, NY1 decision2026–20260 recalls

FDA records 1 decision for Ceiba Healthcare US, Inc. (New York, NY) in 2026: 1 510(k) clearance. All are in product code MSX (System, Network And Communication…). 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2026

2026 (partial year): 1
2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

Planning a device like Ceiba Healthcare US, 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

Which product codes does it file in?

  • MSXSystem, Network And Communication, Physiological Monitors1decision

What has FDA decided for it lately?

  • K260075eClinicsCeiba Healthcare US, Inc. · 2026

The one decision as Ceiba Healthcare US, Inc. →