510(k) · Cleared
Recalled · Class II · 2024Olympus Endoscopic Flushing Pump, Model Opf-2
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 Sep 13, 2010 as substantially equivalent to K000948 (Keymed (Medical & Industrial Equipment), Ltd., 2000) and 2 other predicates after a 166-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Sep 13, 2010
- Review
- 166 days
- Class
- Class II
- Product code
- FEQ
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 3 generations to K933002 (1994). 7 ancestors in all, the oldest K926514 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 2 generations backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
- 1 generation backK073207 Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167Celon AG Medical Instruments · 2008 · Recalled
- This deviceK100899 Olympus Endoscopic Flushing Pump, Model Opf-2Keymed (Medical & Industrial Equipment), Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK241704 Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| −2 | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | Erbe USA, Inc. | 2002 | — |
| −1 | K073207 | Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167 | Celon AG Medical Instruments | 2008 | 1 |
| 0 (this device) | K100899 | Olympus Endoscopic Flushing Pump, Model Opf-2 | Keymed (Medical & Industrial Equipment), Ltd. | 2010 | — |
| +1 | K241704 | Endoscopic Water Pump | Hangzhou AGS MedTech Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K000948 | Olympus Endoscopic Flushing Pump Model Ofp-1Summary page 1…following legally marketed devices: * Olympus Endoscopic Flushing Pump, OFP-1 (K000948) * Olympus AFU-1 00 (K073207) * Olympus U… | 2000 |
| * | K073207 | Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167Summary page 1…* Olympus Endoscopic Flushing Pump, OFP-1 (K000948) * Olympus AFU-1 00 (K073207) * Olympus UWSI Water Supply Unit (K951 994) -.… | 2008 |
| * | K951994 | Olympus EU-M30 Endoscopic Ultrasound CenterSummary page 1…(K000948) * Olympus AFU-1 00 (K073207) * Olympus UWSI Water Supply Unit (K951 994) -. 96… | 1996 |
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 |
|---|---|---|---|
| K241704 | Endoscopic Water Pump | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 23, 2024 | Class II | Z-0229-2025 | Equipment maintenance | During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure. |
| Sep 11, 2015 | Class II | Z-0113-2016 | Process control | small puncture marks in a sterile package for an accessory to an Olympus device |
| May 20, 2013 | Class II | Z-0329-2014 | Component design/selection | There is a possibility that the pump head was not shipped in the locked position. If the pump head is in an unlocked position this may, under certain circumstances, cause the pump to stop and go into power stand-by mode. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K241704 (Hangzhou AGS MedTech Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K000948.
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. 2010, 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 OLYMPUS FLUSHING PUMP (OFP-2) and its accessories are intended for use during endoscopic procedures to wash blood, feces and other organic matter from the gastric and colonic mucosa site being visualized, diagnosed and/or treated and to aid in the filling areas of the gastrointestinal tract with water in order to aid in examinations preformed with trans-endoscopic ultrasound probes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100899 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100899: Olympus Endoscopic Flushing Pump, Model Opf-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100899
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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