510(k) · Cleared
ClearedED-344OT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax Precision Instrument Corp. · FDT Duodenoscope And Accessories, Flexible/Rigid
Cleared on Jul 9, 1996 as substantially equivalent to K951574 (Pentax Precision Instrument Corp., 1996) and 2 other predicates after a 77-day review. Its family tree reaches back 2 generations to 1982.
- Decided
- Jul 9, 1996
- Review
- 77 days
- Class
- Class II
- Product code
- FDT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K822846 (1982). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K822846 | Pentax FC-38LA & FC-38SA Colonofiber | Pentax Precision Instrument Corp. | 1982 | — |
| −1 | K951574 | EC-3800L, Video Colonoscope | Pentax Precision Instrument Corp. | 1996 | 3 |
| 0 (this device) | K961568 | ED-344OT | Pentax Precision Instrument Corp. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1994 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K951574 | EC-3800L, Video ColonoscopeSummary page 1…3440T, Video Duodenoscope Classification Name: Duodenoscope (Esphago Gastro), (FDT),876.1500 3. PREDICATED DEVICE(S) INFORMATION: 1. EC-3800L, Video Colonoscope Pentax K951574 2. FD-34A, Fiber Duodenoscope Pentax K832006 3. EPM-3300 Pentax K934918 4. DEVICE DESCRIPTION: The ED-3440T, Video Duodenoscope… | 1996 |
| * | K832006 | Pentax FD-34A DuodenofiberscopeSummary page 1…: Duodenoscope (Esphago Gastro), (FDT),876.1500 3. PREDICATED DEVICE(S) INFORMATION: 1. EC-3800L, Video Colonoscope Pentax K951574 2. FD-34A, Fiber Duodenoscope Pentax K832006 3. EPM-3300 Pentax K934918 4. DEVICE DESCRIPTION: The ED-3440T, Video Duodenoscope, must be used with a Video Processor (a soft… | 1983 |
| * | K934918 | Epm-3300 Video ProcessorSummary page 1…tro), (FDT),876.1500 3. PREDICATED DEVICE(S) INFORMATION: 1. EC-3800L, Video Colonoscope Pentax K951574 2. FD-34A, Fiber Duodenoscope Pentax K832006 3. EPM-3300 Pentax K934918 4. DEVICE DESCRIPTION: The ED-3440T, Video Duodenoscope, must be used with a Video Processor (a software controlled device). Th… | 1994 |
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 14 years and passes through 1 company; a new generation was cleared every 13.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 7 other devices also cite its predicate K951574.
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.
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 ED-3440T, Video Duodenoscope, is intended to provide visualization (via a video monitor)
of, and therapeutic access to, the Upper Gastrointestinal Tract and Biliary Tract. The Upper
Gastrointestinal Tract and Biliary Tract includes, but is not restricted to, the organs; tissues; and
subsystems: Esophagus, Stomach, Duodenum, Common Bile Duct, Hepatic Duct, and Cystic Duct. The
instrument is introduced per orally when indications consistent with the requirement for the procedure
are observed in Adult and Pediatric patient populations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961568 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961568: ED-344OT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961568
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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