510(k) Report

510(k) · Cleared

Cleared

EndoVac Pure

K162436510(k) TraditionalCleared Dec 21, 2016112-day reviewClass I21 CFR 872.4200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kerr Corporation · NYL Handpiece, Air-Powered, Root Canal Irrigation

Cleared on Dec 21, 2016 as substantially equivalent to K140685 (Sybron Endo, 2014) after a 112-day review. Its family tree reaches back 2 generations to 2006.

Decided
Dec 21, 2016
Review
112 days
Class
Class I
Product code
NYL
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K052271 (2006). No later device cites it as a predicate yet.

K052271 · Rinsendo · Air Techniques, Inc. · 2006K140685 · Endo Vac Apical Negative Pressure Irigation System · Sybron Endo · 20142006200820102012201420162018
K140685 · Endo Vac Apical Negative Pressure Irigation System · Sybron Endo · 2014K052271 · Rinsendo · Air Techniques, Inc. · 20060
  1. Root · 2 generations backK052271 RinsendoAir Techniques, Inc. · 2006
  2. 1 generation backK140685 Endo Vac Apical Negative Pressure Irigation SystemSybron Endo · 2014
  3. This deviceK162436 EndoVac PureKerr Corporation · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K052271RinsendoAir Techniques, Inc.2006—
−1K140685Endo Vac Apical Negative Pressure Irigation SystemSybron Endo2014—
0 (this device)K162436EndoVac PureKerr Corporation2016—
FIG. 1 — Lineage of K162436, 2006–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K211721 PS Systemscore 5.7 · 2 generations · no Class I recall
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K140685Endo Vac Apical Negative Pressure Irigation System
Summary page 4
…. Predicate Device: The EndoVac Pure™ product is substantially equivalent to the legally marketed device EndoVac® Apical Negative Pressure Irrigation System (K140685) cleared on July 2nd, 2014, product code NYL. 4. Description of Device: The EndoVac Pure™ system builds on the EndoV…
Sybron Endo2014—

Also cleared against K140685: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 3 companies; a new generation was cleared every 8.1 years on median.
  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K140685.

How does its category compare?

All NYL devices

NYL Handpiece, Air-Powered, Root Canal Irrigation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · NYL

1in 2021

2010: 12014: 12016: 12021: 1
2007high 1 (2010) · low 0 (2007)2026

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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20101—00
20110—00
20120—00
20130—00
20141—00
20150—00
20161—00
20170—00
20180—00
20190—00
20200—00
20211—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The EndoVac™ Pure System is intended for the delivery and evacuation of endodontic irrigation solutions and removing debris of injured or necrotic pulp tissue 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.

Also cleared against K140685

1 other device cites the same predicate.

  • K211721PS SystemInter-Med, Inc. · 2021

More from Kerr Corporation

32 FDA decisions under this applicant name. See the company

  • K252890ZenSeal ProKerr Corporation · 2026
  • K222830Rainbow 360Kerr Corporation · 2023
  • K221255SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowKerr Corporation · 2022
  • K191548Nexus Universal Self-CureKerr Corporation · 20191 recall
  • K182162OptiBond eXTRa UniversalKerr Corporation · 2018

Recent decisions in NYL

The NYL category page

  • K211721PS SystemInter-Med, Inc. · 2021
  • K140685Endo Vac Apical Negative Pressure Irigation SystemSybron Endo · 2014
  • K100606Vatea Endontic Irrigation SystemRedent Nova, Ltd. · 2010
  • K052271RinsendoAir Techniques, Inc. · 2006

https://510kreport.com/device/K162436 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162436: EndoVac Pure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162436

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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