510(k) Report

510(k) · Cleared

Cleared

Ultramist System, Ultramist Generator, Ultramist Treatment Wand, Ultramist Applicator

K140782510(k) TraditionalCleared Aug 13, 2014135-day reviewClass II21 CFR 878.4410

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Celleration, Inc. · NRB Wound Cleaner, Ultrasound

Cleared on Aug 13, 2014 after a 135-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided
Aug 13, 2014
Review
135 days
Class
Class II
Product code
NRB
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2010201520202025
  1. This deviceK140782 Ultramist System, Ultramist Generator, Ultramist Treatment Wand…Celleration, Inc. · 2014
  2. Descendant · cites it directly · 0 of its ownK162721 Stimucel System, Stimucel Generator, Stimucel Treatment Wand…Alliqua Biomedical, Inc. · 2016

Most influential descendants

Showing 1 of 1 · See all
  • K162721Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel ApplicatorAlliqua Biomedical, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K140782Ultramist System, Ultramist Generator, Ultramist Treatment Wand, Ultramist…Celleration, Inc.2014—
+1K162721Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel…Alliqua Biomedical, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
FIG. 1 — Lineage of K140782, 2014–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NRB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K162721Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel ApplicatorAlliqua Biomedical, Inc.20160

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K162721 (Alliqua Biomedical, Inc., 2016) has gone furthest, with 0 descendants of its own.

How does its category compare?

All NRB devices

NRB Wound Cleaner, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · NRB

1in 2016

2009: 12011: 12012: 12013: 12014: 22016: 1
2007high 2 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NRB

Too few NRB 510(k)s in any year since 2007 to give a median.

Recalls per year · NRB

No recall names NRB since 2007.

Adverse event reports per year · NRB

1in 2025

2007: 32008: 52009: 22010: 12023: 12024: 12025: 1
2007high 5 (2008) · low 0 (2011)2025

MAUDE reports naming product code NRB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—03
20080—05
20091—02
20100—01
20111—00
20121—00
20131—00
20142—00
20150—00
20161—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—01
20240—01
20250—01
20260—0—

What is it indicated for?

MIST Systems produce a low energy ultrasound-generated mist used to promote wound healing through wound cleansing

and maintenance debridement by the removal of fibrin, yellow slough, tissue exudates and bacteria.

Indications for use as stated in the FDA 510(k) statement.

More from Celleration, Inc.

3 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in NRB

The NRB category page

  • K162721Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel ApplicatorAlliqua Biomedical, Inc. · 2016
  • K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2014
  • K123980Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc. · 2013
  • K122246Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case of 12Celleration, Inc. · 2012
  • K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011

https://510kreport.com/device/K140782 · printed Nov 4, 2026

Cite this page

510(k) Report. “K140782: Ultramist System, Ultramist Generator, Ultramist Treatment Wand, Ultramist Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140782

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026