510(k) · Cleared
ClearedFujinon Ultrasonic Processor
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 May 16, 2011 as substantially equivalent to K063847 (Fujinon, Inc., 2007) after a 13-day review. Its family tree reaches back 5 generations to 1982. 1 of the 32 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- May 16, 2011
- Review
- 13 days
- Class
- Class II
- Product code
- FDS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K822846 (1982). 24 ancestors in all, the oldest K812810 (1981). 7 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 · 5 generations backK822846 Pentax FC-38LA & FC-38SA ColonofiberPentax Precision Instrument Corp. · 1982
- 4 generations backK951574 EC-3800L, Video ColonoscopePentax Precision Instrument Corp. · 1996 · Recalled
- 3 generations backK961564 EG-2940, Video GastroscopePentax Precision Instrument Corp. · 1996 · Recalled
- 2 generations backK013640 EG-3630UR, Ultrasund Video GastroscopePentax Precision Instrument Corp. · 2002
- 1 generation backK063847 Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR…Fujinon, Inc. · 2007 · Recalled
- This deviceK111243 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 · cites it directly · 1 of its ownK153206 Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc. · 2016
- Descendant · 4 generations on · 0 of its ownK221238 FUJIFILM Ultrasonic Endoscope EG-740UTFujifilm Corporation · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K850020 Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-234 generations back · 1985
Most influential descendants
Showing 5 of 7 · See all- 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 · cites it directly1descendant
- K221238FUJIFILM Ultrasonic Endoscope EG-740UTFujifilm Corporation · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K822846 | Pentax FC-38LA & FC-38SA Colonofiber | Pentax Precision Instrument Corp. | 1982 | — |
| −4 | K951574 | EC-3800L, Video Colonoscope | Pentax Precision Instrument Corp. | 1996 | 3 |
| −3 | K961564 | EG-2940, Video Gastroscope | Pentax Precision Instrument Corp. | 1996 | 2 |
| −2 | K013640 | EG-3630UR, Ultrasund Video Gastroscope | Pentax Precision Instrument Corp. | 2002 | — |
| −1 | K063847 | Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700 | Fujinon, Inc. | 2007 | 1 |
| 0 (this device) | 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 | — |
| +1 | K153206 | Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 | Fujifilm Medical System U.S.A., Inc. | 2016 | — |
| +4 | K221238 | FUJIFILM Ultrasonic Endoscope EG-740UT | Fujifilm Corporation | 2022 | — |
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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K063847 | Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700Summary page 1…r SU-8000 is a new ultrasonic processor, which can be used with the previously-cleared ultrasonic gastrointestinal endoscopes, EG-530UR and EG- 59OUT via K063847. Fujinon Ultrasonic Processor SU-8000 consists of a scan engine and a function box and SU-8000 is controlled by… | 2007 |
What descends from it? (7)
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)
No FDA recall names this device.
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 · 4 generations back · ◆ in the 1985 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- 11 of the 24 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K120446 (Fujinon, Inc., 2012) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K063847.
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. 2011, 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 ultrasonic processor (SU-8000) is intended to be used in combination with Fujinon/Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111243: Fujinon Ultrasonic Processor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111243
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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