510(k) · Cleared
ClearedFuse Endoscopic System with FuseBox Processor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endochoice, Inc. · PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
Cleared on Aug 1, 2016 as substantially equivalent to K152182 (Endochoice, Inc., 2015) and 1 other predicate after a 181-day review. Its family tree reaches back 10 generations to 1992. 3 of the 57 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 1, 2016
- Review
- 181 days
- Class
- Class II
- Product code
- PEA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K921244 (1992). 56 ancestors in all, the oldest K822846 (1982). No later device cites it as a predicate yet. 3 of the 57 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 6 generations between
- 3 generations backK130718 Peerscope SystemPeermedical, Ltd. · 2013
- 2 generations backK132839 Fuse 1C Colonoscopy SystemEndochoice, Inc. · 2014
- 1 generation backK141598 Fuse Colonoscopy SystemEndochoice, Inc. · 2014 · Recalled
- This deviceK160275 Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc. · 2016
Show all 10 generations
- Root · 10 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 9 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 8 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 7 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 6 generations backK032688 Colonosight Model 510BSightline Technologies, Ltd. · 2004
- 5 generations backK081004 Protectiscope CS Colonoscope, Non-IntrapullStryker GI · 2008
- 4 generations backK120289 Peerscope SystemPeermedical · 2012
- 3 generations backK130718 Peerscope SystemPeermedical, Ltd. · 2013
- 2 generations backK132839 Fuse 1C Colonoscopy SystemEndochoice, Inc. · 2014
- 1 generation backK141598 Fuse Colonoscopy SystemEndochoice, Inc. · 2014 · Recalled
- This deviceK160275 Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc. · 2016
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −9 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −8 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −7 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −6 | K032688 | Colonosight Model 510B | Sightline Technologies, Ltd. | 2004 | — |
| −5 | K081004 | Protectiscope CS Colonoscope, Non-Intrapull | Stryker GI | 2008 | — |
| −4 | K120289 | Peerscope System | Peermedical | 2012 | — |
| −3 | K130718 | Peerscope System | Peermedical, Ltd. | 2013 | — |
| −2 | K132839 | Fuse 1C Colonoscopy System | Endochoice, Inc. | 2014 | — |
| −1 | K141598 | Fuse Colonoscopy System | Endochoice, Inc. | 2014 | 1 |
| 0 (this device) | 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 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 1 |
| 2005 | 2 | 0 |
| 2006 | 2 | 1 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 PEA device
- #1 K251127 PENTAX Medical Video Processor (EPK-i8020c)score 10.7 · 12 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K152182 | Fuse Gastroscopy SystemSummary page 4…Gastroscope And Accessories, FDS Flexible/Rigid III. Predicate Device: Fuse Gastroscopy System K152182 (EndoChoice Inc.) Fuse Colonoscopy System K141598 (EndoChoice Inc.) No reference devices were used in this submission. Fuse… | 2015 |
| * | K141598 | Fuse Colonoscopy SystemSummary page 4…FDS Flexible/Rigid III. Predicate Device: Fuse Gastroscopy System K152182 (EndoChoice Inc.) Fuse Colonoscopy System K141598 (EndoChoice Inc.) No reference devices were used in this submission. Fuse Endoscopy System with FuseBox Page 1 of 5… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 4 generations back · ◆ in the 2006 ancestors bar of 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 · 6 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 20 of the 56 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All PEA devicesPEA Endoscope, Accessories, Image Post-Processing For Color Enhancement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PEA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PEA
Too few PEA 510(k)s in any year since 2007 to give a median.
Recalls per year · PEA
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PEA
60in 2025
MAUDE reports naming product code PEA, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 38 |
| 2019 | 2 | — | 0 | 30 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 201 |
| 2022 | 0 | — | 0 | 66 |
| 2023 | 1 | — | 0 | 78 |
| 2024 | 0 | — | 0 | 103 |
| 2025 | 1 | — | 0 | 60 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Fuse Colonoscopy System The Fuse Colonoscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. Fuse Colonoscopes, in conjunction with the FuseBox® processor, are indicated for use within the lower digestive…
Read the full statement (225 words)
Fuse Colonoscopy System
The Fuse Colonoscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. 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 system includes Lumos, a digital post processing image enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.
Fuse 1G Gastroscopy System
The Fuse 1G Gastroscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. The Fuse 1G Gastroscope, in conjunction with the FuseBox processor, is indicated for use within the upper digestive tract (including the esophagus, stomach and duodenum). The system includes Lumos, a digital post processing image enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160275 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160275: Fuse Endoscopic System with FuseBox Processor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160275
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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