510(k) · Cleared
Recalled · Class II · 2014EG-3830UT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax Precision Instrument Corp. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jun 9, 2004 as substantially equivalent to K023401 (Pentax Precision Instrument Corp., 2003) and 2 other predicates after a 14-day review. Its family tree reaches back 5 generations to 1981. It has been recalled once.
- Decided
- Jun 9, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- ITX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K812810 (1981). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK812810 Pentax Flexible DriodenofiberscopePentax Precision Instrument Corp. · 1981
- 4 generations backK961974 FG-36UX, Ultrasound Upper GI FiberscopePentax Precision Instrument Corp. · 1997 · Recalled
- 3 generations backK010740 FG-36UX, Fiber Ultrasound GastroscopePentax Precision Instrument Corp. · 2001
- 2 generations backK021278 EG-3630UR, Ultrasound Video GastroscopePentax Precision Instrument Corp. · 2002
- 1 generation backK023401 EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp. · 2003
- This deviceK041397 EG-3830UTPentax Precision Instrument Corp. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K812810 | Pentax Flexible Driodenofiberscope | Pentax Precision Instrument Corp. | 1981 | — |
| −4 | K961974 | FG-36UX, Ultrasound Upper GI Fiberscope | Pentax Precision Instrument Corp. | 1997 | 2 |
| −3 | K010740 | FG-36UX, Fiber Ultrasound Gastroscope | Pentax Precision Instrument Corp. | 2001 | — |
| −2 | K021278 | EG-3630UR, Ultrasound Video Gastroscope | Pentax Precision Instrument Corp. | 2002 | — |
| −1 | K023401 | EG-3830UT, Video Ultrasound Gastroscope | Pentax Precision Instrument Corp. | 2003 | — |
| 0 (this device) | K041397 | EG-3830UT | Pentax Precision Instrument Corp. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K023401 | EG-3830UT, Video Ultrasound GastroscopeSummary page 1…ManufacturerPMN# PPIC K023401 EG-3830UT, Video Ultrasound Gastroscope K032503… | 2003 |
| * | K032503 | Eub-5500 Diagnostic Ultrasound ScannerSummary page 1…PPIC K023401 EG-3830UT, Video Ultrasound Gastroscope K032503 Hitachi America EUB-5500, Ultrasound Diagnos… | 2003 |
| * | K013722 | Modification to: Eub-8500 Diagnostic Ultrasound ScannerSummary page 1…Hitachi America EUB-5500, Ultrasound Diagnostic Scanner 013722 Hitachi America K EUB-8500, Ultrasound Diagn… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2014 | Class II | Z-2116-2014 | Device Design | Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This may result in patient injury if the Instruction for Use is not followed carefully by the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- 3 of the 13 ancestors have a recall of any class.
- 2 other devices also cite its predicate K023401.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The EG-3830UT, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes but is 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 the…
Read the full statement (138 words)
The EG-3830UT, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes but is 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 the procedure are observed in Adult and Pediatric patient populations.
The EG-3830UT, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes but is 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 the procedure are observed in Adult and Pediatric patient populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041397 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041397: EG-3830UT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041397
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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