510(k) · Cleared
Recalled · Class II · 2015Fuse Colonoscopy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endochoice, Inc. · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Sep 30, 2014 as substantially equivalent to K132839 (Endochoice, Inc., 2014) after a 109-day review. Its family tree reaches back 9 generations to 1992. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 30, 2014
- Review
- 109 days
- Class
- Class II
- Product code
- FDF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K921244 (1992). 25 ancestors in all, the oldest K822846 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 5 generations between
- 3 generations backK120289 Peerscope SystemPeermedical · 2012
- 2 generations backK130718 Peerscope SystemPeermedical, Ltd. · 2013
- 1 generation backK132839 Fuse 1C Colonoscopy SystemEndochoice, Inc. · 2014
- This deviceK141598 Fuse Colonoscopy SystemEndochoice, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK160275 Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc. · 2016
Show all 9 generations
- Root · 9 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 8 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 7 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 6 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 5 generations backK032688 Colonosight Model 510BSightline Technologies, Ltd. · 2004
- 4 generations backK081004 Protectiscope CS Colonoscope, Non-IntrapullStryker GI · 2008
- 3 generations backK120289 Peerscope SystemPeermedical · 2012
- 2 generations backK130718 Peerscope SystemPeermedical, Ltd. · 2013
- 1 generation backK132839 Fuse 1C Colonoscopy SystemEndochoice, Inc. · 2014
- This deviceK141598 Fuse Colonoscopy SystemEndochoice, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −8 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −7 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −6 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −5 | K032688 | Colonosight Model 510B | Sightline Technologies, Ltd. | 2004 | — |
| −4 | K081004 | Protectiscope CS Colonoscope, Non-Intrapull | Stryker GI | 2008 | — |
| −3 | K120289 | Peerscope System | Peermedical | 2012 | — |
| −2 | K130718 | Peerscope System | Peermedical, Ltd. | 2013 | — |
| −1 | K132839 | Fuse 1C Colonoscopy System | Endochoice, Inc. | 2014 | — |
| 0 (this device) | K141598 | Fuse Colonoscopy System | Endochoice, Inc. | 2014 | — |
| +1 | K160275 | Fuse Endoscopic System with FuseBox Processor | Endochoice, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 FDF? 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 FDF device
- #1 K230332 Ambu® aScope™ Colon; Ambu® aBox™ 2score 20.1 · 8 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 |
|---|---|---|---|
| * | K132839 | Fuse 1C Colonoscopy SystemSummary page 4…accessories Classification: Class II per 21 CFR 876.1500 Product Code: FDF Predicate Device: Fuse™ 1C System (K132839) Reason for Submission: Modification of an existing device. Intended use and indications for use: The Fuse Colono… | 2014 |
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 |
|---|---|---|---|
| K160275 | Fuse Endoscopic System with FuseBox Processor | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 18, 2015 | Class II | Z-0694-2016 | Process design | The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 25 ancestors have a recall of any class.
- Of its descendants, K160275 (Endochoice, Inc., 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FDF devicesFDF Colonoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FDF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDF
194in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDF
8in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDF
17,231in 2025
MAUDE reports naming product code FDF, 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 | 4 | 70 | 0 | 81 |
| 2008 | 2 | — | 0 | 68 |
| 2009 | 6 | 91 | 0 | 83 |
| 2010 | 4 | 101 | 0 | 48 |
| 2011 | 2 | — | 0 | 77 |
| 2012 | 7 | 241 | 0 | 88 |
| 2013 | 2 | — | 0 | 63 |
| 2014 | 6 | 164 | 0 | 60 |
| 2015 | 2 | — | 1 | 100 |
| 2016 | 7 | 98 | 1 | 170 |
| 2017 | 4 | 36 | 0 | 370 |
| 2018 | 7 | 101 | 0 | 388 |
| 2019 | 4 | 56 | 0 | 417 |
| 2020 | 4 | 250 | 1 | 687 |
| 2021 | 3 | 30 | 0 | 2,444 |
| 2022 | 5 | 147 | 0 | 8,345 |
| 2023 | 6 | 203 | 8 | 11,748 |
| 2024 | 2 | — | 0 | 12,128 |
| 2025 | 4 | 194 | 0 | 17,231 |
| 2026 | 5 | 147 | 0 | — |
What is it indicated for?
The Fuse® Colonoscopy System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. Fuse® Colonoscopes, in conjunction with the FuseBox™ processor, are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The Fuse® Colonoscopy System consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141598: Fuse Colonoscopy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141598
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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