510(k) · Cleared
Recalled · 2011Olympus Endoscopic Flushing Pump Model Ofp-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keymed (Medical & Industrial Equipment), Ltd. · FEQ Pump, Air, Non-Manual, For Endoscope
Cleared on May 12, 2000 after a 50-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 64 later devices descend from it. It has been recalled once.
- Decided
- May 12, 2000
- Review
- 50 days
- Class
- Class II
- Product code
- FEQ
- Recalls
- 1
- Predicates
- 0
64 later devices descend from it, 5 citing it directly.
- This deviceK000948 Olympus Endoscopic Flushing Pump Model Ofp-1Keymed (Medical & Industrial Equipment), Ltd. · 2000
- Descendant · cites it directly · 41 of its ownK092429 EndogatorByrne Medical, Inc. · 2009
- Descendant · cites it directly · 13 of its ownK091305 ClearpathEasyglide, Ltd. · 2009
- Descendant · 2 generations on · 10 of its ownK093779 Clearpath UgiEasyglide, Ltd. · 2010
- Descendant · 2 generations on · 8 of its ownK113050 Clearpath Lower GIEasyglide, Ltd. · 2012
- Descendant · 2 generations on · 7 of its ownK220395 EndoGator Endoscopy Irrigation TubingSTERIS Corporation · 2022
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K092429EndogatorByrne Medical, Inc. · 2009 · cites it directly41descendants
- K091305ClearpathEasyglide, Ltd. · 2009 · cites it directly13descendants
- K093779Clearpath UgiEasyglide, Ltd. · 2010 · 2 generations on10descendants
- K113050Clearpath Lower GIEasyglide, Ltd. · 2012 · 2 generations on8descendants
- K220395EndoGator Endoscopy Irrigation TubingSTERIS Corporation · 2022 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000948 | Olympus Endoscopic Flushing Pump Model Ofp-1 | Keymed (Medical & Industrial Equipment), Ltd. | 2000 | — |
| +1 | K092429 | Endogator | Byrne Medical, Inc. | 2009 | — |
| +1 | K091305 | Clearpath | Easyglide, Ltd. | 2009 | — |
| +2 | K093779 | Clearpath Ugi | Easyglide, Ltd. | 2010 | — |
| +2 | K113050 | Clearpath Lower GI | Easyglide, Ltd. | 2012 | — |
| +2 | K220395 | EndoGator Endoscopy Irrigation Tubing | STERIS Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 6 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 9 | 0 |
| 2023 | 9 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (64)
See all 645 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 12, 2011 | Not classified | Z-0806-2012 | Nonconforming Material/Component | Water may leak from the irrigation tubing used on the Olympus Flushing Pump |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K092429 (Byrne Medical, Inc., 2009) has gone furthest, with 41 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.
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 | — |
https://510kreport.com/device/K000948 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000948: Olympus Endoscopic Flushing Pump Model Ofp-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000948
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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