510(k) · Cleared
ClearedEG-3630UR
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 K010740 (Pentax Precision Instrument Corp., 2001) and 2 other predicates after a 14-day review. Its family tree reaches back 3 generations to 1981. 4 later devices descend from it.
- Decided
- Jun 9, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K812810 (1981). 9 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK812810 Pentax Flexible DriodenofiberscopePentax Precision Instrument Corp. · 1981
- 2 generations backK961974 FG-36UX, Ultrasound Upper GI FiberscopePentax Precision Instrument Corp. · 1997 · Recalled
- 1 generation backK010740 FG-36UX, Fiber Ultrasound GastroscopePentax Precision Instrument Corp. · 2001
- This deviceK041395 EG-3630URPentax Precision Instrument Corp. · 2004
- Descendant · cites it directly · 3 of its ownK061068 EG-3670URKPentax Medical Company · 2006 · Recalled
- Descendant · 2 generations on · 2 of its ownK090196 EG-3670URKPentax Medical Company · 2009 · Recalled
- Descendant · 3 generations on · 1 of its ownK130206 Pentax EG-3670URK Ultrasound Video Gastroscope + HI Vision PreirusPentax of America, Inc. · 2013
- Descendant · 4 generations on · 0 of its ownK231813 Ultrasonic GastrovideoscopeSonoscape Medical Corp. · 2024
Most influential descendants
Showing 4 of 4 · See all- K061068EG-3670URKPentax Medical Company · 2006 · cites it directly3descendants
- K090196EG-3670URKPentax Medical Company · 2009 · 2 generations on2descendants
- K130206Pentax EG-3670URK Ultrasound Video Gastroscope + HI Vision PreirusPentax of America, Inc. · 2013 · 3 generations on1descendant
- K231813Ultrasonic GastrovideoscopeSonoscape Medical Corp. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K812810 | Pentax Flexible Driodenofiberscope | Pentax Precision Instrument Corp. | 1981 | — |
| −2 | K961974 | FG-36UX, Ultrasound Upper GI Fiberscope | Pentax Precision Instrument Corp. | 1997 | 2 |
| −1 | K010740 | FG-36UX, Fiber Ultrasound Gastroscope | Pentax Precision Instrument Corp. | 2001 | — |
| 0 (this device) | K041395 | EG-3630UR | Pentax Precision Instrument Corp. | 2004 | — |
| +1 | K061068 | EG-3670URK | Pentax Medical Company | 2006 | 1 |
| +2 | K090196 | EG-3670URK | Pentax Medical Company | 2009 | 1 |
| +3 | K130206 | Pentax EG-3670URK Ultrasound Video Gastroscope + HI Vision Preirus | Pentax of America, Inc. | 2013 | — |
| +4 | K231813 | Ultrasonic Gastrovideoscope | Sonoscape Medical Corp. | 2024 | — |
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 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K010740 | FG-36UX, Fiber Ultrasound GastroscopeSummary page 1…Manufacturer PMN# FG-36UX, Fiber Ultrasound Gastroscope PPIC K010740 Hitachi America K032503 EUB-5500, Ultra… | 2001 |
| * | K032503 | Eub-5500 Diagnostic Ultrasound ScannerSummary page 1…PPIC K010740 Hitachi America K032503 EUB-5500, Ultrasound Diagnostic Scanner EUB-8500, Ultrasound Diaonostic Scanner Hitachi… | 2003 |
| * | K013722 | Modification to: Eub-8500 Diagnostic Ultrasound ScannerSummary page 1…America K032503 EUB-5500, Ultrasound Diagnostic Scanner EUB-8500, Ultrasound Diaonostic Scanner Hitachi America K013722 Device Description: The EG-3630UR, Ultrasound Video Gastroscope, must be used with a Pentax Video Processor (software con… | 2002 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061068 | EG-3670URK | 2006 | 3 |
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?
- The line of descent spans 23 years and passes through 1 company; a new generation was cleared every 4.2 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K061068 (Pentax Medical Company, 2006) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K010740.
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-3630UR, 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.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041395 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041395: EG-3630UR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041395
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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