510(k) · Cleared
ClearedPure Vu System
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 Apr 29, 2021 as substantially equivalent to K191220 (Motus GI Medical Technologies, Ltd., 2019) after a 28-day review. Its family tree reaches back 12 generations to 1992.
- Decided
- Apr 29, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K921244 (1992). 33 ancestors in all, the oldest K822846 (1982). No later device cites it as a predicate yet.
- Root · 12 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 8 generations between
- 3 generations backK173392 Pure-Vu SystemMotus GI Medical Technologies, Ltd. · 2017
- 2 generations backK181437 Pure Vu SystemMotus GI Medical Technologies, Ltd. · 2018
- 1 generation backK191220 Pure Vu SystemMotus GI Medical Technologies, Ltd. · 2019
- This deviceK210981 Pure Vu SystemMotus GI Medical Technologies, Ltd. · 2021
Show all 12 generations
- Root · 12 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 11 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 10 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 9 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 8 generations backK032688 Colonosight Model 510BSightline Technologies, Ltd. · 2004
- 7 generations backK091305 ClearpathEasyglide, Ltd. · 2009
- 6 generations backK093779 Clearpath UgiEasyglide, Ltd. · 2010
- 5 generations backK113050 Clearpath Lower GIEasyglide, Ltd. · 2012
- 4 generations backK160015 Pure VuMotus GI Medical Technologies, Ltd. · 2016
- 3 generations backK173392 Pure-Vu SystemMotus GI Medical Technologies, Ltd. · 2017
- 2 generations backK181437 Pure Vu SystemMotus GI Medical Technologies, Ltd. · 2018
- 1 generation backK191220 Pure Vu SystemMotus GI Medical Technologies, Ltd. · 2019
- This deviceK210981 Pure Vu SystemMotus GI Medical Technologies, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −11 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −10 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −9 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −8 | K032688 | Colonosight Model 510B | Sightline Technologies, Ltd. | 2004 | — |
| −7 | K091305 | Clearpath | Easyglide, Ltd. | 2009 | — |
| −6 | K093779 | Clearpath Ugi | Easyglide, Ltd. | 2010 | — |
| −5 | K113050 | Clearpath Lower GI | Easyglide, Ltd. | 2012 | — |
| −4 | K160015 | Pure Vu | Motus GI Medical Technologies, Ltd. | 2016 | — |
| −3 | K173392 | Pure-Vu System | Motus GI Medical Technologies, Ltd. | 2017 | — |
| −2 | K181437 | Pure Vu System | Motus GI Medical Technologies, Ltd. | 2018 | — |
| −1 | K191220 | Pure Vu System | Motus GI Medical Technologies, Ltd. | 2019 | — |
| 0 (this device) | K210981 | Pure Vu System | Motus GI Medical Technologies, Ltd. | 2021 | — |
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 |
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 |
|---|---|---|---|
| * | K191220 | Pure Vu SystemSummary page 4…essories Regulation No: 876.1500 Class: 11 Classification: Panel: Gastroenterology and Urology Predicate Device(s): Pure Vu System (K191220) Pure-Vu System is intended to connect to standard or slim colonoscopes and gas… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 33 ancestors have a recall of any class.
- 1 other device also cites its predicate K191220.
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. 2021, 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?
Pure-Vu System is intended to connect to standard or slim colonoscopes and gastroscopes to facilitate intra-procedural cleansing of the GI tract by irrigating and evacuating the irrigation fluids (water), bodily fluids and other debris, e.g. blood.
It is for use only by trained medical personnel located in hospitals, clinics and doctors' offices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210981 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210981: Pure Vu System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210981
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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