510(k) Report

FDA applicant

Celleration, Inc.

Eden Prairie, MN4 decisions2004–20140 recalls

FDA records 4 decisions for Celleration, Inc. (Eden Prairie, MN) from 2004 to 2014: 3 510(k) clearances and 1 De Novo grant. All are in product code NRB (Wound Cleaner, Ultrasound). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Celleration”.

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

FDA decisions per year

1in 2014

2012: 12014: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Celleration, Inc.’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

Which product codes does it file in?

  • NRBWound Cleaner, Ultrasound4decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K050129Celleration Mist Therapy System 5.1Celleration, Inc. · 20052cite it
  • DEN040004Celleration Mist Therapy SystemCelleration · 20041cites it
  • K140782Ultramist System, Ultramist Generator, Ultramist Treatment Wand, Ultramist ApplicatorCelleration, Inc. · 20141cites it
  • K122246Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case of 12Celleration, Inc. · 20121cites it

What has FDA decided for it lately?

  • K140782Ultramist System, Ultramist Generator, Ultramist Treatment Wand, Ultramist ApplicatorCelleration, Inc. · 2014
  • K122246Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case of 12Celleration, Inc. · 2012
  • K050129Celleration Mist Therapy System 5.1Celleration, Inc. · 2005
  • DEN040004Celleration Mist Therapy SystemCelleration · 2004

All 3 as Celleration, Inc. →The one decision as Celleration →