510(k) · Cleared
ClearedPentax FD-34A Duodenofiberscope
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 Aug 1, 1983 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Aug 1, 1983
- Review
- 39 days
- Class
- Class II
- Product code
- FDT
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK832006 Pentax FD-34A DuodenofiberscopePentax Precision Instrument Corp. · 1983
- Descendant · cites it directly · 9 of its ownK963056 ED-3410, Video DuodenoscopePentax Precision Instrument Corp. · 1996 · Recalled
- Descendant · 2 generations on · 8 of its ownK092710 Pentax ED-3490TK, Video DuodenoscopePentax Medical Company · 2009 · Recalled
- Descendant · 3 generations on · 6 of its ownK161222 PENTAX MEDICAL ED-3490TK, Video DuodenoscopePentax Medical · 2018 · Recalled
- Descendant · 4 generations on · 5 of its ownK181522 PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical…Pentax of America, Inc. · 2018
- Descendant · 3 generations on · 4 of its ownK163614 PENTAX Medical ED34-i10T, Video DuodenoscopePentax Medical · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K963056ED-3410, Video DuodenoscopePentax Precision Instrument Corp. · 1996 · cites it directly9descendants
- K092710Pentax ED-3490TK, Video DuodenoscopePentax Medical Company · 2009 · 2 generations on8descendants
- K161222PENTAX MEDICAL ED-3490TK, Video DuodenoscopePentax Medical · 2018 · 3 generations on6descendants
- K181522PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video DuodenoscopePentax of America, Inc. · 2018 · 4 generations on5descendants
- K163614PENTAX Medical ED34-i10T, Video DuodenoscopePentax Medical · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K832006 | Pentax FD-34A Duodenofiberscope | Pentax Precision Instrument Corp. | 1983 | — |
| +1 | K963056 | ED-3410, Video Duodenoscope | Pentax Precision Instrument Corp. | 1996 | 2 |
| +2 | K092710 | Pentax ED-3490TK, Video Duodenoscope | Pentax Medical Company | 2009 | 2 |
| +3 | K161222 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope | Pentax Medical | 2018 | 1 |
| +4 | K181522 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video… | Pentax of America, Inc. | 2018 | — |
| +3 | K163614 | PENTAX Medical ED34-i10T, Video Duodenoscope | Pentax Medical | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 112 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?
- Of its descendants, K963056 (Pentax Precision Instrument Corp., 1996) has gone furthest, with 9 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.
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 | — |
https://510kreport.com/device/K832006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K832006: Pentax FD-34A Duodenofiberscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K832006
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026