510(k) Report

FDA applicant

Nimbic Systems, Inc.

Houston, TX2 decisions2011–20130 recalls

FDA records 2 decisions for Nimbic Systems, Inc. (Houston, TX) from 2011 to 2013: 2 510(k) clearances. All are in product code ORC (Air Filter Portable Apparatus). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Nimbic Systems, LLC”.

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 Nimbic Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2011: 12013: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Nimbic Systems, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nimbic Systems, 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?

  • ORCAir Filter Portable Apparatus2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K123006Air Barrier System (Abs)Nimbic Systems, Inc. · 20131cites it
  • K092801Abs Blower, Abs Nozzle, Model 1001Nimbic Systems, LLC · 20111cites it

What has FDA decided for it lately?

  • K123006Air Barrier System (Abs)Nimbic Systems, Inc. · 2013
  • K092801Abs Blower, Abs Nozzle, Model 1001Nimbic Systems, LLC · 2011

The one decision as Nimbic Systems, Inc. →The one decision as Nimbic Systems, LLC →