510(k) · Cleared
ClearedEndoChoice Water Bottle Cap System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endochoice, Inc. · FEQ Pump, Air, Non-Manual, For Endoscope
Cleared on Feb 24, 2016 as substantially equivalent to K142155 (Endochoice, Inc., 2015) after a 70-day review. Its family tree reaches back 2 generations to 2012.
- Decided
- Feb 24, 2016
- Review
- 70 days
- Class
- Class II
- Product code
- FEQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K120123 (2012). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 FEQ? 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 FEQ device
- #1 K220395 EndoGator Endoscopy Irrigation Tubingscore 15.6 · 3 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 |
|---|---|---|---|
| * | K142155 | Endochoice Water Bottle Cap SystemSummary page 5…The modified EndoChoice Water Bottle Cap System is substantially equivalent to the legally marketed unmodified EndoChoice Water Bottle Cap System (K142155). A feature comparison of the two devices is shown below. Based on the intended use, technological charac… | 2015 |
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 4 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All FEQ devicesFEQ Pump, Air, Non-Manual, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · FEQ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · FEQ
29in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FEQ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FEQ
341in 2025
MAUDE reports naming product code FEQ, 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 | 1 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 3 | 84 | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 3 | 141 | 0 | 2 |
| 2013 | 1 | — | 1 | 4 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 1 | 1 |
| 2016 | 3 | 29 | 0 | 1 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 22 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 0 | — | 1 | 705 |
| 2025 | 0 | — | 0 | 341 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The EndoChoice water bottle cap system is intended to be used with an air source or carbon dioxide (CO2) with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with commercially available sterile water bottles.
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/K153588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153588: EndoChoice Water Bottle Cap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153588
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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