510(k) · Cleared
ClearedPENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax of America, Inc. · FDT Duodenoscope And Accessories, Flexible/Rigid
Cleared on Jul 9, 2018 as substantially equivalent to K161222 (Pentax Medical, 2018) after a 28-day review. Its family tree reaches back 4 generations to 1983. 5 later devices descend from it.
- Decided
- Jul 9, 2018
- Review
- 28 days
- Class
- Class II
- Product code
- FDT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K832006 (1983). 6 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK832006 Pentax FD-34A DuodenofiberscopePentax Precision Instrument Corp. · 1983
- 3 generations backK963056 ED-3410, Video DuodenoscopePentax Precision Instrument Corp. · 1996 · Recalled
- 2 generations backK092710 Pentax ED-3490TK, Video DuodenoscopePentax Medical Company · 2009 · Recalled
- 1 generation backK161222 PENTAX MEDICAL ED-3490TK, Video DuodenoscopePentax Medical · 2018 · Recalled
- This deviceK181522 PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical…Pentax of America, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK192245 Pentax Medical Video Duodenoscope ED34-i10T2Pentax of America, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK233942 PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical…Pentax of America, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK210710 PENTAX Medical Video Duedenoscope ED34-i10T2Pentax of America, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK202365 Pentax Medical Video Duodenoscope ED32-i10Pentax of America, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK192280 PENTAX Medical ED-3490TK Video DuodenoscopePentax Medical · 2019
Most influential descendants
Showing 5 of 5 · See all- K192245Pentax Medical Video Duodenoscope ED34-i10T2Pentax of America, Inc. · 2019 · cites it directly3descendants
- K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…Pentax of America, Inc. · 2024 · 2 generations on0descendants
- K210710PENTAX Medical Video Duedenoscope ED34-i10T2Pentax of America, Inc. · 2021 · 2 generations on0descendants
- K202365Pentax Medical Video Duodenoscope ED32-i10Pentax of America, Inc. · 2021 · 2 generations on0descendants
- K192280PENTAX Medical ED-3490TK Video DuodenoscopePentax Medical · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K832006 | Pentax FD-34A Duodenofiberscope | Pentax Precision Instrument Corp. | 1983 | — |
| −3 | K963056 | ED-3410, Video Duodenoscope | Pentax Precision Instrument Corp. | 1996 | 2 |
| −2 | K092710 | Pentax ED-3490TK, Video Duodenoscope | Pentax Medical Company | 2009 | 2 |
| −1 | K161222 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope | Pentax Medical | 2018 | 1 |
| 0 (this device) | K181522 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video… | Pentax of America, Inc. | 2018 | — |
| +1 | K192245 | Pentax Medical Video Duodenoscope ED34-i10T2 | Pentax of America, Inc. | 2019 | 1 |
| +2 | K233942 | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video… | Pentax of America, Inc. | 2024 | — |
| +2 | K210710 | PENTAX Medical Video Duedenoscope ED34-i10T2 | Pentax of America, Inc. | 2021 | 1 |
| +2 | K202365 | Pentax Medical Video Duodenoscope ED32-i10 | Pentax of America, Inc. | 2021 | — |
| +1 | K192280 | PENTAX Medical ED-3490TK Video Duodenoscope | Pentax Medical | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2021 | 2 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K161222 | PENTAX MEDICAL ED-3490TK, Video DuodenoscopeSummary page 5…cope and accessories Regulatory Class: Class II Product Code: FDT Predicate Device: PENTAX ED‐3490TK Video Duodenoscope (K161222, clearance received on February 7, 2018) Device Description: These Video Duodenoscopes must be u… | 2018 |
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)
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 35 years and passes through 4 companies; a new generation was cleared every 13.1 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K192245 (Pentax of America, Inc., 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. 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?
The ED-3490TK, Video Duodenoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to the Biliary Tract via the Upper GI Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic, and Cystic Ducts. This instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and…
Read the full statement (143 words)
The ED-3490TK, Video Duodenoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to the Biliary Tract via the Upper GI Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic, and Cystic Ducts. This instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric populations.
The PENTAX Duodenoscope ED34-i10T is intended to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts. These instruments are introduced via the mouth when indications consistent with the need 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/K181522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181522: PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181522
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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