510(k) · Cleared
ClearedHood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
FUJIFILM Healthcare Americas Corporation · FDS Gastroscope And Accessories, Flexible/Rigid
Cleared on Sep 1, 2023 as substantially equivalent to K162749 (Fujifilm Medical Systems U.S.A, Inc., 2017) after a 30-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Sep 1, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- FDS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K993704 (2000). 8 ancestors in all, the oldest K944759 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
- 4 generations backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
- 3 generations backK090116 Fujinon Colonoscope for Double Balloon Enterscopy System Model…Fujinon, Inc. · 2009
- 2 generations backK143556 Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc. · 2015
- 1 generation backK162749 FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc. · 2017
- This deviceK232314 Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)FUJIFILM Healthcare Americas Corporation · 2023
- Descendant · cites it directly · 0 of its ownK242779 Hood (DH-083ST)Fujifilm Corporation · 2024
Most influential descendants
Showing 1 of 1 · See all- K242779Hood (DH-083ST)Fujifilm Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K993704 | Gastro-Intestinal System EN-410WM | Fujinon, Inc. | 2000 | — |
| −4 | K040048 | Fujinon Double Balloon Enteroscopy System | Fujinon, Inc. | 2004 | — |
| −3 | K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 | Fujinon, Inc. | 2009 | — |
| −2 | K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T | Fujifilm Medical Systems U.S.A, Inc. | 2015 | — |
| −1 | K162749 | FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR | Fujifilm Medical Systems U.S.A, Inc. | 2017 | — |
| 0 (this device) | K232314 | Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) | FUJIFILM Healthcare Americas Corporation | 2023 | — |
| +1 | K242779 | Hood (DH-083ST) | Fujifilm Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 FDS? 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 FDS device
- #1 K251708 EvoEndo Single-Use Endoscopy Systemscore 16.5 · 12 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 |
|---|---|---|---|
| * | K162749 | FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRSummary page 4…21 CFR FDF 876.1500 Predicate Devices • Fujifilm Hood Model DH-28GR, DH-29CR, DH-30CR (K162749) K232314… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242779 | Hood (DH-083ST) | 2024 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K242779 (Fujifilm Corporation, 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K162749.
How does its category compare?
All FDS devicesFDS Gastroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FDS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDS
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDS
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDS
18,905in 2025
MAUDE reports naming product code FDS, 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 | 2 | — | 0 | 27 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 1 | — | 0 | 45 |
| 2011 | 1 | — | 0 | 36 |
| 2012 | 3 | 181 | 0 | 35 |
| 2013 | 2 | — | 1 | 8 |
| 2014 | 2 | — | 0 | 23 |
| 2015 | 2 | — | 0 | 29 |
| 2016 | 1 | — | 1 | 108 |
| 2017 | 1 | — | 0 | 178 |
| 2018 | 6 | 167 | 0 | 304 |
| 2019 | 5 | 175 | 0 | 1,376 |
| 2020 | 2 | — | 2 | 601 |
| 2021 | 5 | 78 | 0 | 1,755 |
| 2022 | 2 | — | 0 | 6,216 |
| 2023 | 3 | 133 | 0 | 9,874 |
| 2024 | 5 | 220 | 2 | 9,258 |
| 2025 | 8 | 211 | 0 | 18,905 |
| 2026 | 7 | 164 | 0 | — |
What is it indicated for?
This hood is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232314: Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232314
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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