510(k) · Cleared
ClearedMist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case of 12
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 Aug 13, 2012 after a 17-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, 2012
- Review
- 17 days
- Class
- Class II
- Product code
- NRB
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK122246 Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator…Celleration, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK131096 AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2014
Most influential descendants
Showing 1 of 1 · See all- K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K122246 | Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case… | Celleration, Inc. | 2012 | — |
| +1 | K131096 | AR1000 Series Ultrasonic Wound Therapy System | Arobella Medical, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
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
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.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131096 | AR1000 Series Ultrasonic Wound Therapy System | 2014 | 0 |
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, K131096 (Arobella Medical, LLC, 2014) has gone furthest, with 0 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. 2012, this device’s year, is highlighted.
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 as stated in the FDA 510(k) statement.
https://510kreport.com/device/K122246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122246: Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case of 12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122246
Report an extraction error
Are you the manufacturer?
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