De Novo · Granted
GrantedCelleration Mist Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Celleration · NRB Wound Cleaner, Ultrasound
Granted on Jun 25, 2004 as a new device type through De Novo after a 57-day review. 7 later devices descend from it.
- Decided
- Jun 25, 2004
- Review
- 57 days
- Class
- Class II
- Product code
- NRB
- Recalls
- None
7 later devices descend from it, 1 citing it directly.
- This deviceDEN040004 Celleration Mist Therapy SystemCelleration · 2004
- Descendant · cites it directly · 6 of its ownK050129 Celleration Mist Therapy System 5.1Celleration, Inc. · 2005
- Descendant · 2 generations on · 5 of its ownK062544 AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2007 · Recalled
- Descendant · 3 generations on · 2 of its ownK112782 Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011
- Descendant · 3 generations on · 1 of its ownK072904 Sonoca 180/195 Wound Care SystemSoering GmbH · 2008
- Descendant · 3 generations on · 0 of its ownK131096 AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K050129Celleration Mist Therapy System 5.1Celleration, Inc. · 2005 · cites it directly6descendants
- K062544AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2007 · 2 generations on5descendants
- K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011 · 3 generations on2descendants
- K072904Sonoca 180/195 Wound Care SystemSoering GmbH · 2008 · 3 generations on1descendant
- K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN040004 | Celleration Mist Therapy System | Celleration | 2004 | — |
| +1 | K050129 | Celleration Mist Therapy System 5.1 | Celleration, Inc. | 2005 | — |
| +2 | K062544 | AR1000 Ultrasonic Wound Therapy System | Arobella Medical, LLC | 2007 | 1 |
| +3 | K112782 | Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories | Misonix, Inc. | 2011 | — |
| +3 | K072904 | Sonoca 180/195 Wound Care System | Soering GmbH | 2008 | — |
| +3 | K131096 | AR1000 Series Ultrasonic Wound Therapy System | Arobella Medical, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050129 | Celleration Mist Therapy System 5.1 | 2005 | 6 |
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, K050129 (Celleration, Inc., 2005) has gone furthest, with 6 descendants of its own.
How does its category compare?
All NRB devicesNRB Wound Cleaner, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NRB
1in 2016
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
MAUDE reports naming product code NRB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN040004 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN040004: Celleration Mist Therapy System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN040004
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026