510(k) · Cleared
ClearedFUJIFILM Duodenoscope Model
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · FDT Duodenoscope And Accessories, Flexible/Rigid
Cleared on Oct 2, 2018 as substantially equivalent to K152257 (Fujifilm Medical Systems U.S.A, Inc., 2017) after a 63-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Oct 2, 2018
- Review
- 63 days
- Class
- Class II
- Product code
- FDT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K944759 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK944759 200 Series Gastro-Intestinal Video SystemFujinon, Inc. · 1995 · Recalled
- 2 generations backK042076 Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5Fujinon, Inc. · 2004 · Recalled
- 1 generation backK152257 Fujifilm Duodenoscope Model ED-530XTFujifilm Medical Systems U.S.A, Inc. · 2017 · Recalled
- This deviceK182051 FUJIFILM Duodenoscope ModelFujifilm Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944759 | 200 Series Gastro-Intestinal Video System | Fujinon, Inc. | 1995 | 5 |
| −2 | K042076 | Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5 | Fujinon, Inc. | 2004 | 4 |
| −1 | K152257 | Fujifilm Duodenoscope Model ED-530XT | Fujifilm Medical Systems U.S.A, Inc. | 2017 | 3 |
| 0 (this device) | K182051 | FUJIFILM Duodenoscope Model | Fujifilm Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K152257 | Fujifilm Duodenoscope Model ED-530XTSummary page 4…fication: Endoscope and accessories, 21 C.F.R. § 876.1500 Product Code: FDT Predicate Device: FUJIFILM Duodenoscope Model ED-530XT (K152257) Intended Use / Indications for Use: ED-530XT is intended for the visualization of the duodenum and upper digestive tract, spec… | 2017 |
| † | K163675 | Processor VP-7000, Light Source BL-7000 | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 9.6 years on median.
- 4 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K152257.
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. 2018, 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?
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/K182051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182051: FUJIFILM Duodenoscope Model.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182051
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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