510(k) · Cleared
ClearedEndo Vac Apical Negative Pressure Irigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sybron Endo · NYL Handpiece, Air-Powered, Root Canal Irrigation
Cleared on Jul 2, 2014 as substantially equivalent to K052271 (Air Techniques, Inc., 2006) after a 106-day review. Its family tree reaches back 1 generation to 2006. 3 later devices descend from it.
- Decided
- Jul 2, 2014
- Review
- 106 days
- Class
- Class I
- Product code
- NYL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052271 (2006). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK052271 RinsendoAir Techniques, Inc. · 2006
- This deviceK140685 Endo Vac Apical Negative Pressure Irigation SystemSybron Endo · 2014
- Descendant · cites it directly · 1 of its ownK211721 PS SystemInter-Med, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK233844 OdneCleanOdne AG · 2024
- Descendant · cites it directly · 0 of its ownK162436 EndoVac PureKerr Corporation · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052271 | Rinsendo | Air Techniques, Inc. | 2006 | — |
| 0 (this device) | K140685 | Endo Vac Apical Negative Pressure Irigation System | Sybron Endo | 2014 | — |
| +1 | K211721 | PS System | Inter-Med, Inc. | 2021 | — |
| +2 | K233844 | OdneClean | Odne AG | 2024 | — |
| +1 | K162436 | EndoVac Pure | Kerr Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 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 5.7 · 2 generations · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052271 | RinsendoSummary page 4…EndoVac® Apical Negative Pressure Irrigation System is substantially equivalent to the legally marketed device RinsEndo, manufactured by Air Techniques, K052271 cleared on May 26, 2006, product code NYL. 4. Description of Device: The EndoVac® System is intended for th… | 2006 |
What descends from it? (3)
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?
- Its one ancestor has no recall.
- Of its descendants, K211721 (Inter-Med, Inc., 2021) has gone furthest, with 1 descendant 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. 2014, this device’s year, is highlighted.
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 EndoVac® system is intended for the delivery and evacuation of endodontic irrigation
solutions during root canal procedures.
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/K140685 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140685: Endo Vac Apical Negative Pressure Irigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140685
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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