510(k) · Cleared
ClearedEndoscope Model EG-580UT and Endoscope Model EG-580UR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Cleared on Aug 4, 2022 as substantially equivalent to K183433 (Fujifilm Corporation, 2019) after a 30-day review. Its family tree reaches back 9 generations to 1982. 1 of the 29 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 4, 2022
- Review
- 30 days
- Class
- Class II
- Product code
- ODG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K822846 (1982). 28 ancestors in all, the oldest K812810 (1981). No later device cites it as a predicate yet. 1 of the 29 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK822846 Pentax FC-38LA & FC-38SA ColonofiberPentax Precision Instrument Corp. · 1982
- 5 generations between
- 3 generations backK120446 Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc. · 2012 · Recalled
- 2 generations backK181763 FUJIFILM Ultrasonic EndoscopeFujifilm Corporation · 2018
- 1 generation backK183433 FUJIFILM Ultrasonic EndoscopeFujifilm Corporation · 2019
- This deviceK221952 Endoscope Model EG-580UT and Endoscope Model EG-580URFujifilm Corporation · 2022
Show all 9 generations
- Root · 9 generations backK822846 Pentax FC-38LA & FC-38SA ColonofiberPentax Precision Instrument Corp. · 1982
- 8 generations backK951574 EC-3800L, Video ColonoscopePentax Precision Instrument Corp. · 1996 · Recalled
- 7 generations backK961564 EG-2940, Video GastroscopePentax Precision Instrument Corp. · 1996 · Recalled
- 6 generations backK013640 EG-3630UR, Ultrasund Video GastroscopePentax Precision Instrument Corp. · 2002
- 5 generations backK063847 Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR…Fujinon, Inc. · 2007 · Recalled
- 4 generations backK111243 Fujinon Ultrasonic ProcessorFujinon, Inc. · 2011
- 3 generations backK120446 Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc. · 2012 · Recalled
- 2 generations backK181763 FUJIFILM Ultrasonic EndoscopeFujifilm Corporation · 2018
- 1 generation backK183433 FUJIFILM Ultrasonic EndoscopeFujifilm Corporation · 2019
- This deviceK221952 Endoscope Model EG-580UT and Endoscope Model EG-580URFujifilm Corporation · 2022
Class I recalls in this family
- K850020 Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-237 generations back · 1985
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K822846 | Pentax FC-38LA & FC-38SA Colonofiber | Pentax Precision Instrument Corp. | 1982 | — |
| −8 | K951574 | EC-3800L, Video Colonoscope | Pentax Precision Instrument Corp. | 1996 | 3 |
| −7 | K961564 | EG-2940, Video Gastroscope | Pentax Precision Instrument Corp. | 1996 | 2 |
| −6 | K013640 | EG-3630UR, Ultrasund Video Gastroscope | Pentax Precision Instrument Corp. | 2002 | — |
| −5 | K063847 | Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700 | Fujinon, Inc. | 2007 | 1 |
| −4 | K111243 | Fujinon Ultrasonic Processor | Fujinon, Inc. | 2011 | — |
| −3 | K120446 | Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2 | Fujinon, Inc. | 2012 | 1 |
| −2 | K181763 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | 2018 | — |
| −1 | K183433 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | 2019 | — |
| 0 (this device) | K221952 | Endoscope Model EG-580UT and Endoscope Model EG-580UR | 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 |
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 ODG device
- #1 K251859 EVIS EUS Ultrasound Gastrointestinal…score 14.0 · 4 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 |
|---|---|---|---|
| * | K183433 | FUJIFILM Ultrasonic EndoscopeSummary page 4…Transducer, Ultrasonic, Diagnostic Review Panel: Gastroenterology/Urology Predicate Device(s): Endoscope Models EG-580UT and EG-580UR (K183433) Intended Use / Indications for Use: Endoscope Model EG-580UT FUJIFILM Endoscope Model EG-580UT is intended to provide ultrason… | 2019 |
| † | K183456 | Aloka Arietta 850 | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 7 generations back · ◆ in the 1985 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 40 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 12 of the 28 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K183433.
How does its category compare?
All ODG devicesODG Endoscopic Ultrasound System, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · ODG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODG
71in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODG
4in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODG
3,569in 2025
MAUDE reports naming product code ODG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 2 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 11 |
| 2016 | 1 | — | 0 | 50 |
| 2017 | 4 | 75 | 0 | 82 |
| 2018 | 3 | 30 | 0 | 66 |
| 2019 | 1 | — | 0 | 96 |
| 2020 | 2 | — | 4 | 445 |
| 2021 | 1 | — | 0 | 1,234 |
| 2022 | 4 | 71 | 0 | 1,832 |
| 2023 | 1 | — | 0 | 2,078 |
| 2024 | 1 | — | 0 | 1,904 |
| 2025 | 2 | — | 0 | 3,569 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
Endoscope Model EG-580UT FUJIFILM Endoscope Model EG-580UT is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. This product is intended to be used with a FUJIFILM ultrasonic processor. This product is not intended for use on children and infants. Endoscope Model EG-580UR FUJIFILM Endoscope Model EG-580UR is intended to provide ultrasonic…
Read the full statement (104 words)
Endoscope Model EG-580UT
FUJIFILM Endoscope Model EG-580UT is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment.
This product is intended to be used with a FUJIFILM ultrasonic processor.
This product is not intended for use on children and infants.
Endoscope Model EG-580UR
FUJIFILM Endoscope Model EG-580UR is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment.
This product is intended to be used with a FUJIFILM ultrasonic processor.
This product is not intended for use on children and infants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221952 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221952: Endoscope Model EG-580UT and Endoscope Model EG-580UR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221952
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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