510(k) · Cleared
ClearedOlympus Flushing Pump Ofp Model: Ofp-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keymed, Inc. · FEQ Pump, Air, Non-Manual, For Endoscope
Cleared on Apr 22, 2010 as substantially equivalent to K000948 (Keymed (Medical & Industrial Equipment), Ltd., 2000) after a 31-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Apr 22, 2010
- Review
- 31 days
- Class
- Class II
- Product code
- FEQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000948 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000948 Olympus Endoscopic Flushing Pump Model Ofp-1Keymed (Medical & Industrial Equipment), Ltd. · 2000 · Recalled
- This deviceK100803 Olympus Flushing Pump Ofp Model: Ofp-1Keymed, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000948 | Olympus Endoscopic Flushing Pump Model Ofp-1 | Keymed (Medical & Industrial Equipment), Ltd. | 2000 | 1 |
| 0 (this device) | K100803 | Olympus Flushing Pump Ofp Model: Ofp-1 | Keymed, Inc. | 2010 | — |
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 |
|---|---|---|---|
| * | K000948 | Olympus Endoscopic Flushing Pump Model Ofp-1Summary page 1…es Panel as a Class II device per 21 CFR 876.1500, Product Code FEQ. 5. PREDICATE DEVICES The predicate device is the Olympus OFP cleared on May 12, 2000 under K000948. 6. DEVICE DESCRIPTION The Olympus Flushing Punp, is peristaltic pump which facilitates direct washing of debris fro… | 2000 |
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 a recall.
- 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 OFF is indicated for use during GI endoscopy, when blood, faeces or other organic matter obscure the endloscopic view, to wash the site being visualized.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100803: Olympus Flushing Pump Ofp 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/K100803
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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