# K011314: Olympus GF UC140P-AL5 Ultrasonic Endoscope with Aloka SSD-5500 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Aloka Co., Ltd.
- Decided: May 15, 2001 after 15 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
73 later devices descend from it; 4 cite it directly.
1 of 74 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K031347: Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8 (2003), 44 descendants of its own
- K042140: Olympus BF Type UC160-OL8 (2004), 43 descendants of its own
- K050503: Single Use Aspiration Needle NA-201SX-4022 (2005), 28 descendants of its own
- K051541: GF-UE160-AL5 Ultrasound Endoscope (2005), 27 descendants of its own
- K063683: Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic Gastrovideoscope (2007), 15 descendants of its own

## Recalls of this device
- Sep 25, 2023 · Class II · Z-0333-2024: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the poten
- Mar 18, 2022 · Class II · Z-1034-2022: GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
- Oct 16, 2020 · Class II · Z-0498-2021: A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
- Oct 16, 2020 · Class II · Z-0499-2021: A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.

Source page: https://510kreport.com/device/K011314
Methodology: https://510kreport.com/methodology