510(k) · Cleared
Recalled · Class II · 2016FG-36UX, Ultrasound Upper GI Fiberscope
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 Feb 10, 1997 as substantially equivalent to K904573 (Pentax Precision Instrument Corp., 1991) and 3 other predicates after a 266-day review. Its family tree reaches back 1 generation to 1981. 1 of the 91 devices in its family, counting itself, has a Class I recall. 86 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 10, 1997
- Review
- 266 days
- Class
- Class II
- Product code
- ITX
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 1 generation to K812810 (1981). 4 ancestors in all. 86 later devices descend from it, 3 citing it directly. 1 of the 91 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK812810 Pentax Flexible DriodenofiberscopePentax Precision Instrument Corp. · 1981
- This deviceK961974 FG-36UX, Ultrasound Upper GI FiberscopePentax Precision Instrument Corp. · 1997
- Descendant · cites it directly · 59 of its ownK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
- Descendant · 2 generations on · 44 of its ownK031347 Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003
- Descendant · 2 generations on · 43 of its ownK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- Descendant · 3 generations on · 28 of its ownK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled
- Descendant · cites it directly · 16 of its ownK010740 FG-36UX, Fiber Ultrasound GastroscopePentax Precision Instrument Corp. · 2001
Showing 5 of 86 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193517 ViziShot 2 FLEX6 generations on · 2020
Most influential descendants
Showing 5 of 86 · See all- K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · cites it directly59descendants
- K031347Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003 · 2 generations on44descendants
- K042140Olympus BF Type UC160-OL8Olympus Corporation · 2004 · 2 generations on43descendants
- K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · 3 generations on28descendants
- K010740FG-36UX, Fiber Ultrasound GastroscopePentax Precision Instrument Corp. · 2001 · cites it directly16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K812810 | Pentax Flexible Driodenofiberscope | Pentax Precision Instrument Corp. | 1981 | — |
| 0 (this device) | K961974 | FG-36UX, Ultrasound Upper GI Fiberscope | Pentax Precision Instrument Corp. | 1997 | — |
| +1 | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | 2001 | 2 |
| +2 | K031347 | Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8 | Olympus Optical Co., Ltd. | 2003 | — |
| +2 | K042140 | Olympus BF Type UC160-OL8 | Olympus Corporation | 2004 | 1 |
| +3 | K050503 | Single Use Aspiration Needle NA-201SX-4022 | Olympus Medical Systems Corporation | 2005 | 5 |
| +1 | K010740 | FG-36UX, Fiber Ultrasound Gastroscope | Pentax Precision Instrument Corp. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 4 | 0 |
| 2018 | 6 | 0 |
| 2019 | 7 | 0 |
| 2020 | 6 | 1 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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.
1 device in this family has a Class I recall. 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? (4)
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 |
|---|---|---|---|
| * | K904573 | Pentax Ultrasound Endoscope, Model FG-32UASummary page 1…oscope and Accessories (78KOG) {876.1500} PREDICATED DEVICE(S) INFORMATION: FG-32UA, Ultrasound Upper GI Fiberscope With Hitachi Scanner EUB: 410, 450, 515, 565 Pentax K904573 With Hitachi Scanner EUB 555 Penatx K953876 FD-32A, Fiber Duodenoscope Pentax K812810 EUB-405, Ultrasound Scanner Hitachi K92412… | 1991 |
| * | K953876 | Pentax Ultrasound Endoscope Model FG-32UA (Modification)Summary page 1…EDICATED DEVICE(S) INFORMATION: FG-32UA, Ultrasound Upper GI Fiberscope With Hitachi Scanner EUB: 410, 450, 515, 565 Pentax K904573 With Hitachi Scanner EUB 555 Penatx K953876 FD-32A, Fiber Duodenoscope Pentax K812810 EUB-405, Ultrasound Scanner Hitachi K924126 DEVICE DESCRIPTION: iy The FG-36UX Ultraso… | 1995 |
| * | K812810 | Pentax Flexible DriodenofiberscopeSummary page 1…ltrasound Upper GI Fiberscope With Hitachi Scanner EUB: 410, 450, 515, 565 Pentax K904573 With Hitachi Scanner EUB 555 Penatx K953876 FD-32A, Fiber Duodenoscope Pentax K812810 EUB-405, Ultrasound Scanner Hitachi K924126 DEVICE DESCRIPTION: iy The FG-36UX Ultrasound Fiber Gastroscope, can be used with an… | 1981 |
| * | K924126 | EUB-405Summary page 1…Scanner EUB: 410, 450, 515, 565 Pentax K904573 With Hitachi Scanner EUB 555 Penatx K953876 FD-32A, Fiber Duodenoscope Pentax K812810 EUB-405, Ultrasound Scanner Hitachi K924126 DEVICE DESCRIPTION: iy The FG-36UX Ultrasound Fiber Gastroscope, can be used with any Endoscopic Light Source (with the appropri… | 1992 |
What descends from it? (86)
See all 863 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2016 | Class II | Z-2077-2016 | Device Design | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel. |
| Apr 6, 2016 | Class II | Z-2279-2016 | Device Design | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- None of the 4 ancestors has a recall.
- Of its descendants, K010591 (Olympus Optical Co., Ltd., 2001) has gone furthest, with 59 descendants of its own.
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 FG-36UX, Ultrasound Fiber Gastroscope, is intended to provide optical and sonographic visualization of and therapeutic access to, the Upper Gastrointestinal Tract. The Upper GI Gastrointestinal Tract includes, but is not limited to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when the indications consistent with the requirement for procedure(s) are observed in Adult and Pediatric patient populations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961974 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961974: FG-36UX, Ultrasound Upper GI Fiberscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961974
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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