510(k) · Cleared
ClearedZutron Medical Endoscope Leak Tester Model Zutr-10003
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zutron Medical, LLC · FCY Bulb, Inflation, For Endoscope
Cleared on Feb 22, 2010 after an 82-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Feb 22, 2010
- Review
- 82 days
- Class
- Class I
- Product code
- FCY
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK093718 Zutron Medical Endoscope Leak Tester Model Zutr-10003Zutron Medical, LLC · 2010
- Descendant · cites it directly · 1 of its ownK123704 Automated Endoscope Leak TesterOlympus Medical Systems Corp. · 2013
- Descendant · 2 generations on · 0 of its ownK212201 PENTAX Medical Auto Leakage Tester SHA-P6Pentax of America, Inc. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093718 | Zutron Medical Endoscope Leak Tester Model Zutr-10003 | Zutron Medical, LLC | 2010 | — |
| +1 | K123704 | Automated Endoscope Leak Tester | Olympus Medical Systems Corp. | 2013 | — |
| +2 | K212201 | PENTAX Medical Auto Leakage Tester SHA-P6 | Pentax of America, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2021 | 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 FCY? 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? (3)
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 |
|---|---|---|---|
| * | — | Fujinon Leak Tester Named without a submission number | |
| * | — | SRI Leak Tester Named without a submission number | |
| * | — | Telemed Systems Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123704 | Automated Endoscope Leak Tester | 2013 | 1 |
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, K123704 (Olympus Medical Systems Corp., 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FCY devicesFCY Bulb, Inflation, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FCY
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · FCY
Too few FCY 510(k)s in any year since 2007 to give a median.
Recalls per year · FCY
No recall names FCY since 2007.
Adverse event reports per year · FCY
13in 2021
MAUDE reports naming product code FCY, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 13 |
| 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 Zutron Medical ZUTR-1003 Endoscope Leak Tester is designed to detect interior and exterior leaks in endoscopes.
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/K093718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093718: Zutron Medical Endoscope Leak Tester Model Zutr-10003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093718
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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