510(k) Report

FDA applicant

Arobella Medical, LLC

Minnetonka, MN3 decisions2007–20141 recall

FDA records 3 decisions for Arobella Medical, LLC (Minnetonka, MN) from 2007 to 2014: 3 510(k) clearances. Most are in product codes NRB (Wound Cleaner, Ultrasound) and LFL (Instrument, Ultrasonic Surgical). Its devices cite 12 predicates, 2 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, general and plastic surgery panel, where it files most

How often FDA has decided Arobella Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007: 12009: 12014: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Arobella Medical, LLC’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?

  • NRBWound Cleaner, Ultrasound2decisions
  • LFLInstrument, Ultrasonic Surgical1decision

Whose devices does it build on?

Its devices cite 12 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 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.

  • K062544AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 20074cite it

What has FDA decided for it lately?

  • K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2014
  • K091038AS 1000 Ultrasound Wound Therapy SystemArobella Medical, LLC · 2009
  • K062544AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 20071 recall

All 3 as Arobella Medical, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K062544Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System.…Nov 5, 2012Class II