510(k) Report

FDA applicant

Unetixs, Inc.

Providence, RI1 decision1991–19914 recalls

FDA records 1 decision for Unetixs, Inc. (Providence, RI) in 1991: 1 510(k) clearance. All are in product code JAF (Monitor, Ultrasonic, Nonfetal). 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Unetixs, Inc. since 2007.

Recalls per year

4in 2023

2023: 4
2007high 4 (2023) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • JAFMonitor, Ultrasonic, Nonfetal1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K904392Multilab 2000Unetixs, Inc. · 19911cites it

What has FDA decided for it lately?

  • K904392Multilab 2000Unetixs, Inc. · 19914 recalls

The one decision as Unetixs, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K904392MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number…Feb 10, 2023Class II
  • K904392MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number…Feb 10, 2023Class II
  • K904392MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model…Feb 10, 2023Class II
  • K904392MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number…Feb 10, 2023Class II