510(k) · Cleared
Recalled · Class II · 2017Fujifilm Duodenoscope Model ED-530XT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical Systems U.S.A, Inc. · FDT Duodenoscope And Accessories, Flexible/Rigid
Cleared on Jul 21, 2017 as substantially equivalent to K042076 (Fujinon, Inc., 2004) after a 711-day review. Its family tree reaches back 2 generations to 1995. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 21, 2017
- Review
- 711 days
- Class
- Class II
- Product code
- FDT
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944759 (1995). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK944759 200 Series Gastro-Intestinal Video SystemFujinon, Inc. · 1995 · Recalled
- 1 generation backK042076 Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5Fujinon, Inc. · 2004 · Recalled
- This deviceK152257 Fujifilm Duodenoscope Model ED-530XTFujifilm Medical Systems U.S.A, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK181745 FUJIFILM Duodenoscope ModelFujifilm Corporation · 2019
- Descendant · 2 generations on · 2 of its ownK191747 FUJIFILM Duodenoscope Model ED-580XTFujifilm Corporation · 2019
- Descendant · 3 generations on · 0 of its ownK251861 FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model…Fujifilm Corporation · 2026
- Descendant · 3 generations on · 0 of its ownK203028 FUJIFILM Distal End CapFujifilm Corporation · 2020
- Descendant · cites it directly · 0 of its ownK182051 FUJIFILM Duodenoscope ModelFujifilm Corporation · 2018
Most influential descendants
Showing 5 of 5 · See all- K181745FUJIFILM Duodenoscope ModelFujifilm Corporation · 2019 · cites it directly3descendants
- K191747FUJIFILM Duodenoscope Model ED-580XTFujifilm Corporation · 2019 · 2 generations on2descendants
- K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…Fujifilm Corporation · 2026 · 3 generations on0descendants
- K203028FUJIFILM Distal End CapFujifilm Corporation · 2020 · 3 generations on0descendants
- K182051FUJIFILM Duodenoscope ModelFujifilm Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944759 | 200 Series Gastro-Intestinal Video System | Fujinon, Inc. | 1995 | 5 |
| −1 | K042076 | Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5 | Fujinon, Inc. | 2004 | 4 |
| 0 (this device) | K152257 | Fujifilm Duodenoscope Model ED-530XT | Fujifilm Medical Systems U.S.A, Inc. | 2017 | — |
| +1 | K181745 | FUJIFILM Duodenoscope Model | Fujifilm Corporation | 2019 | — |
| +2 | K191747 | FUJIFILM Duodenoscope Model ED-580XT | Fujifilm Corporation | 2019 | — |
| +3 | K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP… | Fujifilm Corporation | 2026 | — |
| +3 | K203028 | FUJIFILM Distal End Cap | Fujifilm Corporation | 2020 | — |
| +1 | K182051 | FUJIFILM Duodenoscope Model | Fujifilm Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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 FDT? 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 FDT device
- #1 K251861 FUJIFILM Endoscope Model ED-S100TP; FUJIFILM…score 13.7 · 10 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 |
|---|---|---|---|
| * | K042076 | Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5Summary page 4…ope and Accessories (Flexible/Rigid), 21 C.F.R. § 876.1500 Product Code: FDT Primary Predicate Fujinon G5 Duodenoscope ED-450XT5 / ED-250XT5 (K042076) \\DC - 038036/000001 - 10478113 v1… | 2004 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 21, 2017 | Class II | Z-3225-2017 | Device Design | An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap… |
| Mar 9, 2015 | Class II | Z-3128-2017 | Other | Fujifilm is reporting a corrective action due to an FDA inspection. |
| Mar 9, 2015 | Class II | Z-3129-2017 | Other | Fujifilm is conducting a corrective action due to an FDA inspection. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 12.7 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K181745 (Fujifilm Corporation, 2019) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FDT devicesFDT Duodenoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · FDT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDT
72in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDT
7so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDT
3,946in 2025
MAUDE reports naming product code FDT, 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 | 4 |
| 2008 | 1 | — | 0 | 11 |
| 2009 | 1 | — | 0 | 18 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 1 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 1 | 246 |
| 2016 | 1 | — | 1 | 247 |
| 2017 | 2 | — | 0 | 791 |
| 2018 | 3 | 63 | 1 | 481 |
| 2019 | 5 | 88 | 0 | 1,347 |
| 2020 | 4 | 72 | 0 | 822 |
| 2021 | 2 | — | 1 | 1,270 |
| 2022 | 1 | — | 0 | 2,619 |
| 2023 | 0 | — | 3 | 3,050 |
| 2024 | 2 | — | 0 | 3,019 |
| 2025 | 2 | — | 1 | 3,946 |
| 2026 | 2 | — | 7 | — |
What is it indicated for?
The Fujifilm Duodenoscope Model ED-530XT is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152257 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152257: Fujifilm Duodenoscope Model ED-530XT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152257
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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