510(k) Report

FDA applicant

Ingeneron, Inc.

Houston, TX2 decisions2014–20140 recalls

FDA records 2 decisions for Ingeneron, Inc. (Houston, TX) in 2014: 2 510(k) clearances. All are in product code MUU (System, Suction, Lipoplasty). Its devices cite 4 predicates, 0 of them its own earlier devices. 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

2in 2014

2014: 2
2014high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

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

Planning a device like Ingeneron, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MUUSystem, Suction, Lipoplasty2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K141713Smartgraft 200 SystemIngeneron, Inc. · 2014
  • K141591Smartgraft 30 SystemIngeneron, Inc. · 2014

All 2 as Ingeneron, Inc. →