510(k) · Cleared
ClearedCelleration Mist Therapy System 5.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Celleration, Inc. · NRB Wound Cleaner, Ultrasound
Cleared on May 17, 2005 as substantially equivalent to DEN040004 (Celleration, 2004) and 3 other predicates after a 118-day review. Its family tree reaches back 3 generations to 1995. 6 later devices descend from it.
- Decided
- May 17, 2005
- Review
- 118 days
- Class
- Class II
- Product code
- NRB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K945062 (1995). 8 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 2 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 1 generation backK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · Recalled
- This deviceK050129 Celleration Mist Therapy System 5.1Celleration, Inc. · 2005
- Descendant · cites it directly · 5 of its ownK062544 AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2007 · Recalled
- Descendant · 2 generations on · 2 of its ownK112782 Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK072904 Sonoca 180/195 Wound Care SystemSoering GmbH · 2008
- Descendant · 2 generations on · 0 of its ownK131096 AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2014
- Descendant · 3 generations on · 0 of its ownK123980 Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K062544AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2007 · cites it directly5descendants
- K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011 · 2 generations on2descendants
- K072904Sonoca 180/195 Wound Care SystemSoering GmbH · 2008 · 2 generations on1descendant
- K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2014 · 2 generations on0descendants
- K123980Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc. · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −2 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −1 | K032310 | Mini V.a.C., V.a.C. Freedom, V.a.C. Ats | Kinetic Concepts, Inc. | 2003 | 2 |
| 0 (this device) | K050129 | Celleration Mist Therapy System 5.1 | Celleration, Inc. | 2005 | — |
| +1 | K062544 | AR1000 Ultrasonic Wound Therapy System | Arobella Medical, LLC | 2007 | 1 |
| +2 | K112782 | Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories | Misonix, Inc. | 2011 | — |
| +2 | K072904 | Sonoca 180/195 Wound Care System | Soering GmbH | 2008 | — |
| +2 | K131096 | AR1000 Series Ultrasonic Wound Therapy System | Arobella Medical, LLC | 2014 | — |
| +3 | K123980 | Sonicone Plus Ultrasound Wound Care System and Accessories | Misonix, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
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
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN040004 | Celleration Mist Therapy System Our OCR of the scanned summary read K032378, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN040004, Celleration Mist Therapy System (Celleration), granted Jun 25, 2004; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2004 |
| * | K032310 | Mini V.a.C., V.a.C. Freedom, V.a.C. AtsSummary page 1…cation Name: Low Energy Ultrasound Wound Cleaner (21CFR 878.4410) Predicate Device(s): o MIST Therapy System 5.0 (K032378) e VAC. ®ATS™ mini VAC.®, V.A.C.® Freedom™ (K032310) * NeoGen One, Closed Wound Drainage System (K032301) *_ Blue Sky Versatile 1 Wound Vacuum System (K042134) Device Description:… | 2003 |
| * | K032301 | Neogen One, Closed Wound Drain System, Part Number: NG9900Summary page 1…CFR 878.4410) Predicate Device(s): o MIST Therapy System 5.0 (K032378) e VAC. ®ATS™ mini VAC.®, V.A.C.® Freedom™ (K032310) * NeoGen One, Closed Wound Drainage System (K032301) *_ Blue Sky Versatile 1 Wound Vacuum System (K042134) Device Description: MIST Therapy System is a non-contact, low-energy ul… | 2003 |
| * | K042134 | Versatile 1 Wound Vacuum SystemSummary page 1…tem 5.0 (K032378) e VAC. ®ATS™ mini VAC.®, V.A.C.® Freedom™ (K032310) * NeoGen One, Closed Wound Drainage System (K032301) *_ Blue Sky Versatile 1 Wound Vacuum System (K042134) Device Description: MIST Therapy System is a non-contact, low-energy ultrasound device, which utilizes continuous ultrasonic e… | 2004 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K062544 (Arobella Medical, LLC, 2007) has gone furthest, with 5 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 | — |
What is it indicated for?
The MIST Therapy System produces 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K050129 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050129: Celleration Mist Therapy System 5.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050129
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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