510(k) · Cleared
ClearedPENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )
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 Aug 1, 2024 as substantially equivalent to K192245 (Pentax of America, Inc., 2019) and 1 other predicate after a 231-day review. Its family tree reaches back 12 generations to 1993. 4 of the 42 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 1, 2024
- Review
- 231 days
- Class
- Class II
- Product code
- FDT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K931154 (1993). 41 ancestors in all, the oldest K832006 (1983). No later device cites it as a predicate yet. 4 of the 42 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 8 generations between
- 3 generations backK143727 PENTAX Medical EKP-i5010 Video Processor with EB FamilyPentax of America, Inc. · 2015
- 2 generations backK173679 PENTAX Medical EPK-i7010 Video Processor with EB Family of ScopesPentax of America, Inc. · 2018
- 1 generation backK232860 PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video…Pentax of America, Inc. · 2024
- This deviceK233942 PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical…Pentax of America, Inc. · 2024
Show all 12 generations
- Root · 12 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 11 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 10 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 9 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 8 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 7 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 6 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 5 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 4 generations backK121959 Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · Recalled (Class I)
- 3 generations backK143727 PENTAX Medical EKP-i5010 Video Processor with EB FamilyPentax of America, Inc. · 2015
- 2 generations backK173679 PENTAX Medical EPK-i7010 Video Processor with EB Family of ScopesPentax of America, Inc. · 2018
- 1 generation backK232860 PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video…Pentax of America, Inc. · 2024
- This deviceK233942 PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical…Pentax of America, Inc. · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −11 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −10 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −9 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −8 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −7 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −6 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −5 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| −4 | K121959 | Evis Exera Iii Video System | Olympus Medical Systems Corp. | 2013 | Class I |
| −3 | K143727 | PENTAX Medical EKP-i5010 Video Processor with EB Family | Pentax of America, Inc. | 2015 | — |
| −2 | K173679 | PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes | Pentax of America, Inc. | 2018 | — |
| −1 | K232860 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope… | Pentax of America, Inc. | 2024 | — |
| 0 (this device) | K233942 | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video… | Pentax of America, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 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.
4 devices in this family have a Class I recall. 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? (2)
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 6…K233942 A previously cleared PENTAX Medical Video Duodenoscope ED34-i10T2 (K192245) has Page 2 of 6 been chosen as a predicate device and a recently cleared version of the EPK-i8020c as the seco… | 2019 |
| * | K232860 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10… Cleared while this submission was under review Summary page 6…4-i10T2 (K192245) has Page 2 of 6 been chosen as a predicate device and a recently cleared version of the EPK-i8020c as the secondary predicate device (K232860) 4. DEVICE DESCRIPTION PENTAX Medical Video Duodenoscope ED34-i10T2s is designed to be used with a PENTAX Medical Video Proces… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · 4 generations back · ◆ on the line of descent in FIG. 18 Class I recalls
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 5 generations back · ◆ on the line of descent in FIG. 16 Class I recalls
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 7 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 21 of the 41 ancestors have a recall of any class; 4 have a Class I recall.
- 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. 2024, 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?
PENTAX Medical Video Duodenoscope ED34-i10T2s The PENTAX Medical Video Duodenoscope ED34-i10T2s 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 the biliary tract via the upper gastrointestinal tract. This anatomy includes the organs; tissues; and subsystems of the: esophagus, stomach, duodenum, common bile duct, hepatic ducts, cystic duct…
Read the full statement (300 words)
PENTAX Medical Video Duodenoscope ED34-i10T2s
The PENTAX Medical Video Duodenoscope ED34-i10T2s 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 the biliary tract via the upper gastrointestinal tract. This anatomy includes the organs; tissues; and subsystems of the: esophagus, stomach, duodenum, common bile duct, hepatic ducts, cystic duct, and pancreatic duct.
This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
PENTAX Gas/Water Feeding Valve OF-B194
Gas/water feeding valve is attached in place of air/water feeding valve to the gastrointestinal endoscope, in order to prevent the leaking of the nonflammable gas into the room, and feed the gas or water into the gastrointestinal tract or abdominal cavity. It also prevents back flow/splashing of body fluids.
PENTAX Medical Video Processor EPK-i8020c
The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal and pulmonary endoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i802Oc includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes and bronchoscopes.
PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63
The PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63 fully integrates a movable elevator, whose function it is to guide endoscopic devices. The OE-A63 is controlled by the PENTAX Medical Video Duodenoscopes and is necessary to meet the intended use of the duodenoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233942: PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233942
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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