510(k) Report

FDA applicant

Cibernet Systems Corp.

Ann Arbor, MI1 decision2005–20054 recalls

FDA records 1 decision for Cibernet Systems Corp. (Ann Arbor, MI) in 2005: 1 510(k) clearance. All are in product code DXH (Transmitters And Receivers…). Its devices cite 3 predicates, 0 of them its own earlier devices. 4 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 Cibernet Systems Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cibernet Systems Corp. since 2007.

Recalls per year

4in 2008

2008: 4
2007high 4 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Cibernet Systems Corp.’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