# K100899: Olympus Endoscopic Flushing Pump, Model Opf-2

- Pathway: 510(k) (Traditional)
- Applicant: Keymed (Medical & Industrial Equipment), Ltd.
- Decided: Sep 13, 2010 after 166 days
- Product code: FEQ (Pump, Air, Non-Manual, For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K933002 (1994). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000948: Olympus Endoscopic Flushing Pump Model Ofp-1, Keymed (Medical & Industrial Equipment), Ltd. (2000) Summary page 1.
- K073207: Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167, Celon AG Medical Instruments (2008) Summary page 1.
- K951994: Olympus EU-M30 Endoscopic Ultrasound Center, Olympus America, Inc. (1996) Summary page 1.

## Most influential descendants
- K241704: Endoscopic Water Pump (2025), 0 descendants of its own

## Recalls of this device
- Aug 23, 2024 · Class II · Z-0229-2025: 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: small puncture marks in a sterile package for an accessory to an Olympus device
- May 20, 2013 · Class II · Z-0329-2014: 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 

## Indications for use
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.

Source page: https://510kreport.com/device/K100899
Methodology: https://510kreport.com/methodology