510(k) · Cleared
ClearedPure Vu
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Motus GI Medical Technologies, Ltd. · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Sep 22, 2016 as substantially equivalent to K113050 (Easyglide, Ltd., 2012) after a 262-day review. Its family tree reaches back 8 generations to 1992. 7 later devices descend from it.
- Decided
- Sep 22, 2016
- Review
- 262 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K921244 (1992). 29 ancestors in all, the oldest K822846 (1982). 7 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 7 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 6 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 5 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 4 generations backK032688 Colonosight Model 510BSightline Technologies, Ltd. · 2004
- 3 generations backK091305 ClearpathEasyglide, Ltd. · 2009
- 2 generations backK093779 Clearpath UgiEasyglide, Ltd. · 2010
- 1 generation backK113050 Clearpath Lower GIEasyglide, Ltd. · 2012
- This deviceK160015 Pure VuMotus GI Medical Technologies, Ltd. · 2016
- Descendant · cites it directly · 6 of its ownK173392 Pure-Vu SystemMotus GI Medical Technologies, Ltd. · 2017
- Descendant · 2 generations on · 5 of its ownK181437 Pure Vu SystemMotus GI Medical Technologies, Ltd. · 2018
- Descendant · 3 generations on · 4 of its ownK191220 Pure Vu SystemMotus GI Medical Technologies, Ltd. · 2019
- Descendant · 4 generations on · 2 of its ownK220007 Pure-Vu EVS SystemMotus GI Medical Technologies, Ltd. · 2022
- Descendant · 5 generations on · 1 of its ownK232922 Pure-Vu EVS SystemMotus GI Medical Technologies, Ltd. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K173392Pure-Vu SystemMotus GI Medical Technologies, Ltd. · 2017 · cites it directly6descendants
- K181437Pure Vu SystemMotus GI Medical Technologies, Ltd. · 2018 · 2 generations on5descendants
- K191220Pure Vu SystemMotus GI Medical Technologies, Ltd. · 2019 · 3 generations on4descendants
- K220007Pure-Vu EVS SystemMotus GI Medical Technologies, Ltd. · 2022 · 4 generations on2descendants
- K232922Pure-Vu EVS SystemMotus GI Medical Technologies, Ltd. · 2023 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −7 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −6 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −5 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −4 | K032688 | Colonosight Model 510B | Sightline Technologies, Ltd. | 2004 | — |
| −3 | K091305 | Clearpath | Easyglide, Ltd. | 2009 | — |
| −2 | K093779 | Clearpath Ugi | Easyglide, Ltd. | 2010 | — |
| −1 | K113050 | Clearpath Lower GI | Easyglide, Ltd. | 2012 | — |
| 0 (this device) | K160015 | Pure Vu | Motus GI Medical Technologies, Ltd. | 2016 | — |
| +1 | K173392 | Pure-Vu System | Motus GI Medical Technologies, Ltd. | 2017 | — |
| +2 | K181437 | Pure Vu System | Motus GI Medical Technologies, Ltd. | 2018 | — |
| +3 | K191220 | Pure Vu System | Motus GI Medical Technologies, Ltd. | 2019 | — |
| +4 | K220007 | Pure-Vu EVS System | Motus GI Medical Technologies, Ltd. | 2022 | — |
| +5 | K232922 | Pure-Vu EVS System | Motus GI Medical Technologies, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K113050 | Clearpath Lower GISummary page 4…logy and Urology Predicate Device(s): ClearPath Lower GI (manufactured by EasyGlide Ltd. and the subject of 510(k) documents no. K113050) 5-2 Motus GI Medical Technologies Ltd. 51… | 2012 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173392 | Pure-Vu System | 2017 | 6 |
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 24 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 4 of the 29 ancestors have a recall of any class.
- Of its descendants, K173392 (Motus GI Medical Technologies, Ltd., 2017) has gone furthest, with 6 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. 2016, 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 Pure Vu System is intended to connect to standard colonoscopes to help facilitate intraprocedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.
It is for use only by trained medical personnel located in hospitals, clinics and doctor offices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160015: Pure Vu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160015
Report an extraction error
Are you the manufacturer?
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