# K090197: EG-3870UTK

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Medical Company
- Decided: May 19, 2009 after 112 days
- Product code: ODG (Endoscopic Ultrasound System, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K812810 (1981). 12 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023401: EG-3830UT, Video Ultrasound Gastroscope, Pentax Precision Instrument Corp. (2003) Summary page 1.
- K063518: HI Vision 900 Diagnostic Ultrasound Scanner, Hitachi Medical Systems America, Inc. (2006) Summary page 1.

## Most influential descendants
- K130247: Pentax EG-3870UTK Ultrasound Video Gastroscope + HI Vision Preirus (2013), 5 descendants of its own
- K162447: PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner (2017), 4 descendants of its own
- K182004: PENTAX Medical Endoscopic Ultrasound System (2018), 3 descendants of its own
- K200090: PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) (2020), 2 descendants of its own
- K232518: EndoSound Vision System; EVS (2023), 0 descendants of its own

## Recalls of this device
- May 23, 2017 · Class II · Z-3068-2017: Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the clean
- Mar 14, 2012 · Not classified · Z-1489-2012: Endoscope ultrasound balloon evacuation tube may become clogged with patient body fluid if users fail to properly follow instructions for pre-procedure check, operating the suction valve during proced

## Indications for use
The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations. Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows

Source page: https://510kreport.com/device/K090197
Methodology: https://510kreport.com/methodology