510(k) · Cleared
Recalled · Class II · 2017Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujinon, Inc. · FDS Gastroscope And Accessories, Flexible/Rigid
Cleared on Mar 1, 2007 as substantially equivalent to K013640 (Pentax Precision Instrument Corp., 2002) and 3 other predicates after a 64-day review. Its family tree reaches back 4 generations to 1982. 1 of the 32 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it. It has been recalled once.
- Decided
- Mar 1, 2007
- Review
- 64 days
- Class
- Class II
- Product code
- FDS
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K822846 (1982). 23 ancestors in all, the oldest K812810 (1981). 8 later devices descend from it, 2 citing it directly. 1 of the 32 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK822846 Pentax FC-38LA & FC-38SA ColonofiberPentax Precision Instrument Corp. · 1982
- 3 generations backK951574 EC-3800L, Video ColonoscopePentax Precision Instrument Corp. · 1996 · Recalled
- 2 generations backK961564 EG-2940, Video GastroscopePentax Precision Instrument Corp. · 1996 · Recalled
- 1 generation backK013640 EG-3630UR, Ultrasund Video GastroscopePentax Precision Instrument Corp. · 2002
- This deviceK063847 Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR…Fujinon, Inc. · 2007
- Descendant · cites it directly · 7 of its ownK111243 Fujinon Ultrasonic ProcessorFujinon, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK120446 Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 3 of its ownK181763 FUJIFILM Ultrasonic EndoscopeFujifilm Corporation · 2018
- Descendant · 3 generations on · 2 of its ownK183433 FUJIFILM Ultrasonic EndoscopeFujifilm Corporation · 2019
- Descendant · 2 generations on · 1 of its ownK153206 Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc. · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K850020 Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-233 generations back · 1985
Most influential descendants
Showing 5 of 8 · See all- K111243Fujinon Ultrasonic ProcessorFujinon, Inc. · 2011 · cites it directly7descendants
- K120446Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc. · 2012 · cites it directly4descendants
- K181763FUJIFILM Ultrasonic EndoscopeFujifilm Corporation · 2018 · 2 generations on3descendants
- K183433FUJIFILM Ultrasonic EndoscopeFujifilm Corporation · 2019 · 3 generations on2descendants
- K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc. · 2016 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K822846 | Pentax FC-38LA & FC-38SA Colonofiber | Pentax Precision Instrument Corp. | 1982 | — |
| −3 | K951574 | EC-3800L, Video Colonoscope | Pentax Precision Instrument Corp. | 1996 | 3 |
| −2 | K961564 | EG-2940, Video Gastroscope | Pentax Precision Instrument Corp. | 1996 | 2 |
| −1 | K013640 | EG-3630UR, Ultrasund Video Gastroscope | Pentax Precision Instrument Corp. | 2002 | — |
| 0 (this device) | K063847 | Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700 | Fujinon, Inc. | 2007 | — |
| +1 | K111243 | Fujinon Ultrasonic Processor | Fujinon, Inc. | 2011 | — |
| +1 | K120446 | Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2 | Fujinon, Inc. | 2012 | 1 |
| +2 | K181763 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | 2018 | — |
| +3 | K183433 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | 2019 | — |
| +2 | K153206 | Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 | Fujifilm Medical System U.S.A., Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 1 | 1 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 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 FDS device
- #1 K251708 EvoEndo Single-Use Endoscopy Systemscore 16.5 · 12 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 |
|---|---|---|---|
| * | K013640 | EG-3630UR, Ultrasund Video Gastroscope | 2002 |
| * | K051541 | GF-UE160-AL5 Ultrasound EndoscopeSummary page 2…[21 CFR 807.92(a)(3)] Ultrasonic Endoscopes * Pentax EG-3630UR Ultrasound Video Gastroscope (KO13640) * Olympus GF-UE160-AL5 Endoscope (K051541) The subject devices are substantially equivalent to the predicate devices. The indications for use are simi… | 2005 |
| * | K994026 | Eub-6000 Ultrasound Diagnostic ScannerSummary page 2…nd total length are almost identical. Each endoscope uses different ultrasonic proces- sors. Ultrasound Processors * Hitachi EUB-6000 (K994026 and KO11252) The subject device is substantially equivalent to the predicate device. The indications for use are similar… | 2000 |
| * | K011252 | Eub-6000 Diagnostic Ultrasound Scanner SP-711 Sonoprobe System | 2001 |
What descends from it? (8)
2 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 |
|---|---|---|---|---|
| Feb 17, 2017 | Class II | Z-2706-2017 | Other | Fujifilm is recalling multiple endoscopes after a retrospective review. |
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.
- K850020Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-23Pentax Precision Instrument Corp. · 1985 · 3 generations back · ◆ in the 1985 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- 10 of the 23 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K111243 (Fujinon, Inc., 2011) has gone furthest, with 7 descendants of its own.
How does its category compare?
All FDS devicesFDS Gastroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FDS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDS
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDS
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDS
18,905in 2025
MAUDE reports naming product code FDS, 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 | 2 | — | 0 | 27 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 1 | — | 0 | 45 |
| 2011 | 1 | — | 0 | 36 |
| 2012 | 3 | 181 | 0 | 35 |
| 2013 | 2 | — | 1 | 8 |
| 2014 | 2 | — | 0 | 23 |
| 2015 | 2 | — | 0 | 29 |
| 2016 | 1 | — | 1 | 108 |
| 2017 | 1 | — | 0 | 178 |
| 2018 | 6 | 167 | 0 | 304 |
| 2019 | 5 | 175 | 0 | 1,376 |
| 2020 | 2 | — | 2 | 601 |
| 2021 | 5 | 78 | 0 | 1,755 |
| 2022 | 2 | — | 0 | 6,216 |
| 2023 | 3 | 133 | 0 | 9,874 |
| 2024 | 5 | 220 | 2 | 9,258 |
| 2025 | 8 | 211 | 0 | 18,905 |
| 2026 | 7 | 164 | 0 | — |
What is it indicated for?
The EG-530UR and EG-530UT ultrasonic endoscopes are intended to be used with the SU-7000 ultrasound processor. The system is used for the observation and diagnosis of the upper digestive tract (including the esophagus, stomach, duodenum, and underlying areas), as well as observation and diagnosis of submucosal and peripheral organs using ultrasonic images, and endoscopic treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063847 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063847: Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063847
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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