510(k) · Cleared
ClearedPS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inter-Med, Inc. · NYL Handpiece, Air-Powered, Root Canal Irrigation
Cleared on Dec 2, 2021 as substantially equivalent to K140685 (Sybron Endo, 2014) after a 181-day review. Its family tree reaches back 2 generations to 2006. 1 later device descends from it.
- Decided
- Dec 2, 2021
- Review
- 181 days
- Class
- Class I
- Product code
- NYL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K052271 (2006). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K233844OdneCleanOdne AG · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K052271 | Rinsendo | Air Techniques, Inc. | 2006 | — |
| −1 | K140685 | Endo Vac Apical Negative Pressure Irigation System | Sybron Endo | 2014 | — |
| 0 (this device) | K211721 | PS System | Inter-Med, Inc. | 2021 | — |
| +1 | K233844 | OdneClean | Odne AG | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K140685 | Endo Vac Apical Negative Pressure Irigation SystemSummary page 4…Class I 3. Predicate Device The PS System is substantially equivalent to the legally marketed device Endo Vac Apical Negative Pressure Irrigation System (K140685), submitted by Sybron Endo and cleared on July 2nd, 2014, product code NYL. 4. Device Description The PS System pr… | 2014 |
| † | K082470 | Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower Surface Tension… | 2009 |
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 |
|---|---|---|---|
| K233844 | OdneClean | 2024 | 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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K233844 (Odne AG, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K140685.
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. 2021, 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 PS 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/K211721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211721: PS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211721
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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