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 Jan 25, 2012 as substantially equivalent to K101146 (United States Endoscopy Group, Inc., 2010) after a 141-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Jan 25, 2012
- Review
- 141 days
- Class
- Class II
- Product code
- FEQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K101146 (2010). No later device cites it as a predicate yet.
- Root · 1 generation backK101146 Water Bottle Cap SystemUnited States Endoscopy Group, Inc. · 2010
- This deviceK112576 Endochoice Water Bottle Cap SystemEndochoice, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K101146 | Water Bottle Cap System | United States Endoscopy Group, Inc. | 2010 | — |
| 0 (this device) | K112576 | Endochoice Water Bottle Cap System | Endochoice, Inc. | 2012 | — |
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 |
|---|---|---|---|
| * | K101146 | Water Bottle Cap System | 2010 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K101146.
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. 2012, 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 EndloChoice water bottle cap system is intended to be used with an air source from an endoscope with the purpose of supplying sterile water to the endloscope during endoscopic procedures. It is compatible with commercially available sterile water bottles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112576: 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/K112576
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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