510(k) · Cleared
Recalled · Class II · 2019Flex Robotic System and Flex Colorectal Drive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medrobotics Corporation · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on May 4, 2017 as substantially equivalent to K070622 (Neoguide Systems, Inc., 2007) after a 258-day review. Its family tree reaches back 7 generations to 1992. 1 later device descends from it. It has been recalled 2 times.
- Decided
- May 4, 2017
- Review
- 258 days
- Class
- Class II
- Product code
- FDF
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 7 generations to K921244 (1992). 30 ancestors in all, the oldest K822846 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 6 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 5 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 4 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 3 generations backK032688 Colonosight Model 510BSightline Technologies, Ltd. · 2004
- 2 generations backK052930 Navigator Endoscopy SystemNeoguide Systems, Inc. · 2006
- 1 generation backK070622 Neoguide Endoscopy SystemNeoguide Systems, Inc. · 2007
- This deviceK162330 Flex Robotic System and Flex Colorectal DriveMedrobotics Corporation · 2017
- Descendant · cites it directly · 0 of its ownK172036 Medrobotics Flex Robotic SystemMedrobotics Corporation · 2017
Most influential descendants
Showing 1 of 1 · See all- K172036Medrobotics Flex Robotic SystemMedrobotics Corporation · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −6 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −5 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −4 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −3 | K032688 | Colonosight Model 510B | Sightline Technologies, Ltd. | 2004 | — |
| −2 | K052930 | Navigator Endoscopy System | Neoguide Systems, Inc. | 2006 | — |
| −1 | K070622 | Neoguide Endoscopy System | Neoguide Systems, Inc. | 2007 | — |
| 0 (this device) | K162330 | Flex Robotic System and Flex Colorectal Drive | Medrobotics Corporation | 2017 | — |
| +1 | K172036 | Medrobotics Flex Robotic System | Medrobotics Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K070622 | Neoguide Endoscopy SystemSummary page 4…and accessories Product Code FDF Classification Class II Predicate Device The NeoGuide Navigator Endoscopy System, K070622 Reference Device The Flex® Robotic System and Flex® Colorectal Drive were also co… | 2007 |
| † | K150776 | Medrobotics Flex System | 2015 |
| † | K945209 | Proctoscopea & Accessories, Sigmoidoscopes & Accessories, Proctology Instruments | 1995 |
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 |
|---|---|---|---|
| K172036 | Medrobotics Flex Robotic System | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 25, 2019 | Class II | Z-1192-2019 | Process control | The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators. |
| Jan 25, 2019 | Class II | Z-1191-2019 | Process control | The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 30 ancestors have a recall of any class.
- Of its descendants, K172036 (Medrobotics Corporation, 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K070622.
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. 2017, 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 Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (≥22 years of age).
The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (≥22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162330: Flex Robotic System and Flex Colorectal Drive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162330
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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