510(k) · Cleared
ClearedRinsendo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Air Techniques, Inc. · NYL Handpiece, Air-Powered, Root Canal Irrigation
Cleared on May 26, 2006 after a 280-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- May 26, 2006
- Review
- 280 days
- Class
- Class I
- Product code
- NYL
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK052271 RinsendoAir Techniques, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK140685 Endo Vac Apical Negative Pressure Irigation SystemSybron Endo · 2014
- Descendant · 2 generations on · 1 of its ownK211721 PS SystemInter-Med, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK233844 OdneCleanOdne AG · 2024
- Descendant · 2 generations on · 0 of its ownK162436 EndoVac PureKerr Corporation · 2016
Most influential descendants
Showing 4 of 4 · See all- K140685Endo Vac Apical Negative Pressure Irigation SystemSybron Endo · 2014 · cites it directly3descendants
- K211721PS SystemInter-Med, Inc. · 2021 · 2 generations on1descendant
- K233844OdneCleanOdne AG · 2024 · 3 generations on0descendants
- K162436EndoVac PureKerr Corporation · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052271 | Rinsendo | Air Techniques, Inc. | 2006 | — |
| +1 | K140685 | Endo Vac Apical Negative Pressure Irigation System | Sybron Endo | 2014 | — |
| +2 | K211721 | PS System | Inter-Med, Inc. | 2021 | — |
| +3 | K233844 | OdneClean | Odne AG | 2024 | — |
| +2 | K162436 | EndoVac Pure | Kerr Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 NYL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NYL device
- #1 K211721 PS Systemscore 5.8 · 2 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140685 | Endo Vac Apical Negative Pressure Irigation System | 2014 | 3 |
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, K140685 (Sybron Endo, 2014) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NYL devicesNYL Handpiece, Air-Powered, Root Canal Irrigation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NYL
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · NYL
Too few NYL 510(k)s in any year since 2007 to give a median.
Recalls per year · NYL
No recall names NYL since 2007.
Adverse event reports per year · NYL
No MAUDE report names NYL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 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 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RinsEndo is used for root canal irrigation/ disinfection.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K052271 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052271: Rinsendo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052271
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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