510(k) · Cleared
ClearedPENTAX Medical ED-3490TK Video Duodenoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax Medical · FDT Duodenoscope And Accessories, Flexible/Rigid
Cleared on Oct 21, 2019 as substantially equivalent to K181522 (Pentax of America, Inc., 2018) after a 60-day review. Its family tree reaches back 5 generations to 1983.
- Decided
- Oct 21, 2019
- Review
- 60 days
- Class
- Class II
- Product code
- FDT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K832006 (1983). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK832006 Pentax FD-34A DuodenofiberscopePentax Precision Instrument Corp. · 1983
- 4 generations backK963056 ED-3410, Video DuodenoscopePentax Precision Instrument Corp. · 1996 · Recalled
- 3 generations backK092710 Pentax ED-3490TK, Video DuodenoscopePentax Medical Company · 2009 · Recalled
- 2 generations backK161222 PENTAX MEDICAL ED-3490TK, Video DuodenoscopePentax Medical · 2018 · Recalled
- 1 generation backK181522 PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical…Pentax of America, Inc. · 2018
- This deviceK192280 PENTAX Medical ED-3490TK Video DuodenoscopePentax Medical · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K832006 | Pentax FD-34A Duodenofiberscope | Pentax Precision Instrument Corp. | 1983 | — |
| −4 | K963056 | ED-3410, Video Duodenoscope | Pentax Precision Instrument Corp. | 1996 | 2 |
| −3 | K092710 | Pentax ED-3490TK, Video Duodenoscope | Pentax Medical Company | 2009 | 2 |
| −2 | K161222 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope | Pentax Medical | 2018 | 1 |
| −1 | K181522 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video… | Pentax of America, Inc. | 2018 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K181522 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video DuodenoscopeSummary page 4…umber: 21 C.F.R. § 876.1500 Regulatory Class: II Product Code: FDT 3. Predicate Device PENTAX Medical ED-3490TK Video Duodenoscope (K181522) 4. Device Description The PENTAX Medical ED-3490TK Video Duodenoscope is used with a PENTAX compatible Video Processor (softw… | 2018 |
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 36 years and passes through 4 companies; a new generation was cleared every 8.2 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K181522.
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. 2019, 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 PENTAX Medical 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.
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/K192280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192280: PENTAX Medical ED-3490TK 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/K192280
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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