FDA applicant

Mobius Medical Systems, LP

Bellaire, TX3 decisions2014–20161 recall

FDA records 3 decisions for Mobius Medical Systems, LP (Bellaire, TX) from 2014 to 2016: 3 510(k) clearances. All are in product code IYE (Accelerator, Linear, Medical). Its devices cite 6 predicates, 1 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, radiology panel, where it files most

How often FDA has decided Mobius Medical Systems, LP’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2014high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2015

2014high 1 (2015) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Mobius Medical Systems, LP by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mobius Medical Systems, LP’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 “Mobius”

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

Mobius Imaging, LLC 3 Mobius Mobility 2

Mobius Medical Systems, LP

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 “Mobius”