510(k) Report

510(k) · Cleared

Cleared

Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator

K162721510(k) SpecialCleared Dec 22, 201684-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

Alliqua Biomedical, Inc. · NRB Wound Cleaner, Ultrasound

Cleared on Dec 22, 2016 as substantially equivalent to K140782 (Celleration, Inc., 2014) after an 84-day review. Its family tree reaches back 1 generation to 2014.

Decided
Dec 22, 2016
Review
84 days
Class
Class II
Product code
NRB
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K140782 (2014). No later device cites it as a predicate yet.

K140782 · Ultramist System, Ultramist Generator, Ultramist Treatment Wand, Ultramist Applicator · Celleration, Inc. · 201420102012201420162018
K140782 · Ultramist System, Ultramist Generator, Ultramist Treatment Wand, Ultramist Applicator · Celleration, Inc. · 20140
  1. Root · 1 generation backK140782 Ultramist System, Ultramist Generator, Ultramist Treatment Wand…Celleration, Inc. · 2014
  2. This deviceK162721 Stimucel System, Stimucel Generator, Stimucel Treatment Wand…Alliqua Biomedical, Inc. · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K140782Ultramist System, Ultramist Generator, Ultramist Treatment Wand, Ultramist…Celleration, Inc.2014—
0 (this device)K162721Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel…Alliqua Biomedical, Inc.2016—
FIG. 1 — Lineage of K162721, 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 summary (predicates and 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
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K140782Ultramist System, Ultramist Generator, Ultramist Treatment Wand, Ultramist Applicator
Summary page 4
…cturer: Alliqua BioMedical, Inc. 11495 Valley View Road Eden Prairie, MN 55344 Establishment 3004580659 Registration: Predicate K140782, UltraMIST® System Device(s): Manufacturer: Alliqua BioMedical, Inc. Device MIST Systems (e.g., UltraMIST System) a…
Celleration, Inc.2014—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • Its one ancestor has no recall.

How does its category compare?

All NRB devices

NRB Wound Cleaner, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 yellow slough, fibrin, tissue exudates, and bacteria.

Indications for use as stated in the FDA summary.

More from Alliqua Biomedical, Inc.

2 FDA decisions under this applicant name. See the company

  • K171041SilverSealAlliqua Biomedical, Inc. · 2017

Recent decisions in NRB

The NRB category page

  • K140782Ultramist System, Ultramist Generator, Ultramist Treatment Wand, Ultramist ApplicatorCelleration, Inc. · 2014
  • 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/K162721 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162721: Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162721

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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