510(k) · Cleared
Recalled · Class II · 2021PENTAX Medical Video Duedenoscope ED34-i10T2
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 Apr 9, 2021 as substantially equivalent to K192245 (Pentax of America, Inc., 2019) after a 30-day review. Its family tree reaches back 6 generations to 1983. It has been recalled once.
- Decided
- Apr 9, 2021
- Review
- 30 days
- Class
- Class II
- Product code
- FDT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K832006 (1983). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK832006 Pentax FD-34A DuodenofiberscopePentax Precision Instrument Corp. · 1983
- 5 generations backK963056 ED-3410, Video DuodenoscopePentax Precision Instrument Corp. · 1996 · Recalled
- 4 generations backK092710 Pentax ED-3490TK, Video DuodenoscopePentax Medical Company · 2009 · Recalled
- 3 generations backK161222 PENTAX MEDICAL ED-3490TK, Video DuodenoscopePentax Medical · 2018 · Recalled
- 2 generations backK181522 PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical…Pentax of America, Inc. · 2018
- 1 generation backK192245 Pentax Medical Video Duodenoscope ED34-i10T2Pentax of America, Inc. · 2019 · Recalled
- This deviceK210710 PENTAX Medical Video Duedenoscope ED34-i10T2Pentax of America, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K832006 | Pentax FD-34A Duodenofiberscope | Pentax Precision Instrument Corp. | 1983 | — |
| −5 | K963056 | ED-3410, Video Duodenoscope | Pentax Precision Instrument Corp. | 1996 | 2 |
| −4 | K092710 | Pentax ED-3490TK, Video Duodenoscope | Pentax Medical Company | 2009 | 2 |
| −3 | K161222 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope | Pentax Medical | 2018 | 1 |
| −2 | 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 |
| 0 (this device) | K210710 | PENTAX Medical Video Duedenoscope ED34-i10T2 | Pentax of America, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K192245 | Pentax Medical Video Duodenoscope ED34-i10T2Summary page 4…Classification Panel Gastroenterology/ Urology Ill. PREDICATE DEVICES The predicate device for this submission, PENTAX Medical ED34-i10T2 Video Duodenoscope (K192245), is materially, optically, structurally, mechanically identical to the subject device. Device Description: The PENTAX Medical… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2021 | Class II | Z-1682-2021 | Process design | IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope has been updated to notify users of the associated risks with the distal end cap (OE-A63) unexpectedly becoming detached during a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 4 companies; a new generation was cleared every 8.2 years on median.
- 4 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K192245.
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. 2021, 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 Video Duodenoscope ED34-ilOT2 is intended to be used with endoscopic devices and other ancillary equipment 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.
This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210710 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210710: PENTAX Medical Video Duedenoscope ED34-i10T2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210710
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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