510(k) · Cleared
ClearedEndoChoice Water Bottle Cap Irrigation 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 Jun 27, 2016 as substantially equivalent to K133747 (Endochoice, Inc., 2014) after a 27-day review. Its family tree reaches back 5 generations to 1988. 1 later device descends from it.
- Decided
- Jun 27, 2016
- Review
- 27 days
- Class
- Class II
- Product code
- FEQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K884836 (1988). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK884836 Universal Generator Irrigator Model Ugi-3000Meditron Devices, Inc. · 1988
- 4 generations backK031773 Endo Gator SystemByrne Medical, Inc. · 2003
- 3 generations backK092429 EndogatorByrne Medical, Inc. · 2009
- 2 generations backK120862 Water Bottle Cap Irrigaton SystemEndochoice, Inc. · 2012
- 1 generation backK133747 Endochoice Water Bottle Cap Irrigation SystemEndochoice, Inc. · 2014
- This deviceK161482 EndoChoice Water Bottle Cap Irrigation SystemEndochoice, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK181457 EndoStream (TM)Partnership Medical Limited · 2019
Most influential descendants
Showing 1 of 1 · See all- K181457EndoStream (TM)Partnership Medical Limited · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K884836 | Universal Generator Irrigator Model Ugi-3000 | Meditron Devices, Inc. | 1988 | — |
| −4 | K031773 | Endo Gator System | Byrne Medical, Inc. | 2003 | — |
| −3 | K092429 | Endogator | Byrne Medical, Inc. | 2009 | — |
| −2 | K120862 | Water Bottle Cap Irrigaton System | Endochoice, Inc. | 2012 | — |
| −1 | K133747 | Endochoice Water Bottle Cap Irrigation System | Endochoice, Inc. | 2014 | — |
| 0 (this device) | K161482 | EndoChoice Water Bottle Cap Irrigation System | Endochoice, Inc. | 2016 | — |
| +1 | K181457 | EndoStream (TM) | Partnership Medical Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 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 |
|---|---|---|---|
| * | K133747 | Endochoice Water Bottle Cap Irrigation SystemSummary page 5…lence The modified EndoChoice Water Bottle Cap Irrigation System is equivalent to the legally marketed unmodified EndoChoice Water Bottle Cap Irrigation System (K133747). A feature comparison of the two devices is shown below. Based on the intended use, technological characteristics and overal… | 2014 |
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 |
|---|---|---|---|
| K181457 | EndoStream (TM) | 2019 | 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 28 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K181457 (Partnership Medical Limited, 2019) has gone furthest, with 0 descendants of its own.
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 water bottle cap irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161482 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161482: EndoChoice Water Bottle Cap Irrigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161482
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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