510(k) · Cleared
Recalled · Class II · 2023EXALT Model D Single-Use Duodenoscope, EXALT Controller
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · FDT Duodenoscope And Accessories, Flexible/Rigid
Cleared on Dec 13, 2019 as substantially equivalent to K143153 (Olympus Medical Systems Corp., 2016) and 1 other predicate after a 23-day review. Its family tree reaches back 10 generations to 1993. 3 of the 38 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 6 times.
- Decided
- Dec 13, 2019
- Review
- 23 days
- Class
- Class II
- Product code
- FDT
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 10 generations to K931154 (1993). 33 ancestors in all, the oldest K843084 (1985). 4 later devices descend from it, 1 citing it directly. 3 of the 38 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 6 generations between
- 3 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 2 generations backK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- 1 generation backK122831 Video System CenterOlympus Medical Systems Corp. · 2012
- This deviceK193202 EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation · 2019
- Descendant · cites it directly · 3 of its ownK213606 EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK251708 EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK260573 EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK250900 EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 9 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 8 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 7 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 6 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 5 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 4 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 3 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 2 generations backK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- 1 generation backK122831 Video System CenterOlympus Medical Systems Corp. · 2012
- This deviceK193202 EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation · 2019
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2022 · cites it directly3descendants
- K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2025 · 2 generations on1descendant
- K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2026 · 3 generations on0descendants
- K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −9 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −8 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −7 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −6 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −5 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −4 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −3 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| −2 | K112680 | Evis Exera Iii Video System | Olympus Medical Systems Corporation | 2012 | 6 |
| −1 | K122831 | Video System Center | Olympus Medical Systems Corp. | 2012 | — |
| 0 (this device) | K193202 | EXALT Model D Single-Use Duodenoscope, EXALT Controller | Boston Scientific Corporation | 2019 | — |
| +1 | K213606 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2022 | — |
| +2 | K251708 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2025 | — |
| +3 | K260573 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2026 | — |
| +2 | K250900 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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.
3 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 |
|---|---|---|---|
| * | K143153 | Evis Exera II Duodenovideoscope Olympus TJF Type Q180VSummary page 5…ices Trade Name: EVIS EXERA II Duodenovideoscope TJF Type Q180V Manufacturer: Olympus Medical Systems Corp. Clearance Number: K143153 Common Name: Duodenoscope and accessories, flexible/rigid Product Code: FDT Device Class and Panel… | 2016 |
| * | K122831 | Video System CenterSummary page 5…ndoscope and accessories Trade Name: CV-170 Video System Center Manufacturer: Olympus Medical Systems Corp. Clearance Number: K122831 Common Name: Endoscopic video imaging system/component, gastroenterology-urology Pro… | 2012 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213606 | EvoEndo Single-Use Endoscopy System | 2022 | 3 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2023 | Class II | Z-0396-2024 | Process control | Poor image quality due to fluid ingress in the lens. |
| Sep 27, 2023 | Class II | Z-0397-2024 | Process control | Poor image quality due to fluid ingress in the lens. |
| Mar 3, 2022 | Class II | Z-1081-2022 | Device Design | Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device. |
| Mar 3, 2022 | Class II | Z-1079-2022 | Device Design | Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device. |
| Mar 3, 2022 | Class II | Z-1080-2022 | Device Design | Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device. |
| Mar 3, 2022 | Class II | Z-1082-2022 | Device Design | Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device. |
The 5 latest of 6 recalls; the web page lists all.
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.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 4 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 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 5 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 19 of the 33 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K213606 (EvoEndo, Inc., 2022) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K143153.
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 EXALT Model D Single-Use Duodenoscope is intended for use with a Boston Scientific endoscopic video imaging system, for endoscopy and endoscopic surgery within the duodenum.
The EXALT Controller is intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193202 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193202: EXALT Model D Single-Use Duodenoscope, EXALT Controller.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193202
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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