510(k) · Cleared
ClearedFluid Pump, CP #3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Endoscopy Group, Inc. · FEB Accessories, Cleaning, For Endoscope
Cleared on Mar 9, 1994 after an 881-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Mar 9, 1994
- Review
- 881 days
- Class
- Class II
- Product code
- FEB
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK914524 Fluid Pump, CP #3United States Endoscopy Group, Inc. · 1994
- Descendant · cites it directly · 1 of its ownK162128 Scope Buddy Plus Endoscope Flushing AidMedivators, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK213833 SCOPE BUDDY PLUS Endoscope Flushing AidMedivators, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK181865 Acu-sInQ Complete Endoscope Cleaning Aid SystemSTERIS Corporation · 2018 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K162128Scope Buddy Plus Endoscope Flushing AidMedivators, Inc. · 2016 · cites it directly1descendant
- K213833SCOPE BUDDY PLUS Endoscope Flushing AidMedivators, Inc. · 2022 · 2 generations on0descendants
- K181865Acu-sInQ Complete Endoscope Cleaning Aid SystemSTERIS Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914524 | Fluid Pump, CP #3 | United States Endoscopy Group, Inc. | 1994 | — |
| +1 | K162128 | Scope Buddy Plus Endoscope Flushing Aid | Medivators, Inc. | 2016 | — |
| +2 | K213833 | SCOPE BUDDY PLUS Endoscope Flushing Aid | Medivators, Inc. | 2022 | — |
| +1 | K181865 | Acu-sInQ Complete Endoscope Cleaning Aid System | STERIS Corporation | 2018 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FEB? 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 FEB device
- #1 K243433 enspire 3000 Cleaning and Liquid Chemical…score 10.8 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K162128 (Medivators, Inc., 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FEB devicesFEB Accessories, Cleaning, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FEB
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FEB
111in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FEB
15so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FEB
356in 2025
MAUDE reports naming product code FEB, 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 | 2 | — | 0 | 39 |
| 2008 | 1 | — | 3 | 152 |
| 2009 | 1 | — | 0 | 20 |
| 2010 | 2 | — | 1 | 50 |
| 2011 | 3 | 111 | 0 | 32 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 1 | — | 0 | 27 |
| 2014 | 1 | — | 0 | 48 |
| 2015 | 0 | — | 0 | 92 |
| 2016 | 2 | — | 2 | 103 |
| 2017 | 2 | — | 0 | 69 |
| 2018 | 1 | — | 0 | 88 |
| 2019 | 2 | — | 0 | 62 |
| 2020 | 2 | — | 1 | 426 |
| 2021 | 0 | — | 1 | 575 |
| 2022 | 1 | — | 0 | 607 |
| 2023 | 1 | — | 1 | 998 |
| 2024 | 2 | — | 1 | 884 |
| 2025 | 0 | — | 3 | 356 |
| 2026 | 1 | — | 15 | — |
https://510kreport.com/device/K914524 · printed Nov 5, 2026
Cite this page
510(k) Report. “K914524: Fluid Pump, CP #3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K914524
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026