510(k) · Cleared
ClearedFUJIFILM Distal End Cap
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 30, 2020 as substantially equivalent to K191747 (Fujifilm Corporation, 2019) after a 28-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Oct 30, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- FDT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K944759 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK944759 200 Series Gastro-Intestinal Video SystemFujinon, Inc. · 1995 · Recalled
- 4 generations backK042076 Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5Fujinon, Inc. · 2004 · Recalled
- 3 generations backK152257 Fujifilm Duodenoscope Model ED-530XTFujifilm Medical Systems U.S.A, Inc. · 2017 · Recalled
- 2 generations backK181745 FUJIFILM Duodenoscope ModelFujifilm Corporation · 2019
- 1 generation backK191747 FUJIFILM Duodenoscope Model ED-580XTFujifilm Corporation · 2019
- This deviceK203028 FUJIFILM Distal End CapFujifilm Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944759 | 200 Series Gastro-Intestinal Video System | Fujinon, Inc. | 1995 | 5 |
| −4 | K042076 | Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5 | Fujinon, Inc. | 2004 | 4 |
| −3 | K152257 | Fujifilm Duodenoscope Model ED-530XT | Fujifilm Medical Systems U.S.A, Inc. | 2017 | 3 |
| −2 | K181745 | FUJIFILM Duodenoscope Model | Fujifilm Corporation | 2019 | — |
| −1 | K191747 | FUJIFILM Duodenoscope Model ED-580XT | Fujifilm Corporation | 2019 | — |
| 0 (this device) | K203028 | FUJIFILM Distal End Cap | Fujifilm Corporation | 2020 | — |
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 |
|---|---|---|---|
| * | K191747 | FUJIFILM Duodenoscope Model ED-580XTSummary page 4…exible/rigid CFR Section: 21 CFR 876.1500 Product Code: FDT Predicate Device: • FUJIFILM Distal End Cap DC-07D (K191747) Intended Use / Indications for Use This product is a single use distal end cap required to be attached to certain FUJIFILM end… | 2019 |
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 25 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K191747.
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. 2020, 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?
This product is a single use distal end cap required to be attached to certain FUJIFILM endoscopes during clinical use to assist in providing
atraumatic passage of the endoscope tip during endoscopic procedures.
Do not use this product for any other purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203028 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203028: FUJIFILM Distal End Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203028
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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