510(k) · Cleared
ClearedInvendo C20 Colonoscopy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invendo Medical Gbmh · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Feb 23, 2012 as substantially equivalent to K001241 (The Olympus Optical Co., 2000) and 11 other predicates after a 721-day review. Its family tree reaches back 8 generations to 1989. 6 later devices descend from it.
- Decided
- Feb 23, 2012
- Review
- 721 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 8 generations to K894632 (1989). 108 ancestors in all, the oldest K812810 (1981). 6 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 7 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 6 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 5 generations backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- 4 generations backK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
- 3 generations backK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
- 2 generations backK063683 Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic…Olympus Medical Systems Corporation · 2007
- 1 generation backK092156 Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009
- This deviceK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
- Descendant · cites it directly · 5 of its ownK121582 Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012
- Descendant · cites it directly · 2 of its ownK141286 Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK161355 invendoscopy E200 SystemInvendo Medical GmbH · 2016
- Descendant · 2 generations on · 0 of its ownK190669 EndoticsEra Endoscopy S.R.L. · 2020
- Descendant · 2 generations on · 0 of its ownK173085 invendoscopy E210 SystemInvendo Medical GmbH · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012 · cites it directly5descendants
- K141286Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2014 · cites it directly2descendants
- K161355invendoscopy E200 SystemInvendo Medical GmbH · 2016 · cites it directly1descendant
- K190669EndoticsEra Endoscopy S.R.L. · 2020 · 2 generations on0descendants
- K173085invendoscopy E210 SystemInvendo Medical GmbH · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −7 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −6 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −5 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −4 | K994096 | Sonoheart Hand-Carried Echocardiography System | Sonosite,Inc. | 1999 | — |
| −3 | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | 2001 | 2 |
| −2 | K063683 | Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic… | Olympus Medical Systems Corporation | 2007 | — |
| −1 | K092156 | Cad 12, Colonoscopy Assist Device | Softscope Medical Technologies, Inc. | 2009 | — |
| 0 (this device) | K100624 | Invendo C20 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +1 | K121582 | Invendo C25 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +1 | K141286 | Aer-O-Scope Colonoscope System | Gi View, Ltd. | 2014 | — |
| +1 | K161355 | invendoscopy E200 System | Invendo Medical GmbH | 2016 | — |
| +2 | K190669 | Endotics | Era Endoscopy S.R.L. | 2020 | — |
| +2 | K173085 | invendoscopy E210 System | Invendo Medical GmbH | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 9 | 0 |
| 1995 | 6 | 0 |
| 1996 | 12 | 0 |
| 1997 | 11 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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? (12)
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 |
|---|---|---|---|
| * | K001241 | Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/ISummary page 2…): Predicate Device 510(k) No. Olympus CF-Q16OAL/l K001241 Fujinon EN 450P35/20 Double Balloon K040048 ColonoSight 51DB… | 2000 |
| * | K040048 | Fujinon Double Balloon Enteroscopy SystemSummary page 2…k) No. Olympus CF-Q16OAL/l K001241 Fujinon EN 450P35/20 Double Balloon K040048 ColonoSight 51DB K032688 NeoGuideEndloscopy System… | 2004 |
| * | K032688 | Colonosight Model 510BSummary page 2…K001241 Fujinon EN 450P35/20 Double Balloon K040048 ColonoSight 51DB K032688 NeoGuideEndloscopy System K052930;… | 2004 |
| * | K052930 | Navigator Endoscopy SystemSummary page 2…K040048 ColonoSight 51DB K032688 NeoGuideEndloscopy System K052930; K070622 Avantis 3rd Eye Retroscope… | 2006 |
| * | K070622 | Neoguide Endoscopy SystemSummary page 2…2688 NeoGuideEndloscopy System K052930; K070622 Avantis 3rd Eye Retroscope K070330 Softscope CAD 12… | 2007 |
| * | K070330 | Third Eye Retroscope Auxiliary Endoscopy SystemSummary page 2…2930; K070622 Avantis 3rd Eye Retroscope K070330 Softscope CAD 12 K092156 Medela Dominat 35c/i suction pump… | 2007 |
| * | K092156 | Cad 12, Colonoscopy Assist DeviceSummary page 2…70622 Avantis 3rd Eye Retroscope K070330 Softscope CAD 12 K092156 Medela Dominat 35c/i suction pump K043544 Medela Basic 30… | 2009 |
| * | K043544 | Medela Dominant 35 C/I Secretion and Surgical AspiratorSummary page 2…70330 Softscope CAD 12 K092156 Medela Dominat 35c/i suction pump K043544 Medela Basic 30 K021368 PROTOCO2LTM Colon Insufflator with Perfor… | 2005 |
| * | K021368 | Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057Summary page 2…92156 Medela Dominat 35c/i suction pump K043544 Medela Basic 30 K021368 PROTOCO2LTM Colon Insufflator with Performance Improvements K030854 EndloGatorEndloscopy Irrigation Pump… | 2002 |
| * | K030854 | PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400Summary page 2…43544 Medela Basic 30 K021368 PROTOCO2LTM Colon Insufflator with Performance Improvements K030854 EndloGatorEndloscopy Irrigation Pump K060962 Olympus Exera 160A videoprocessor… | 2003 |
| * | K060962 | Endogator Endoscopy Irrigation Pump, Model Egp-100Summary page 2…21368 PROTOCO2LTM Colon Insufflator with Performance Improvements K030854 EndloGatorEndloscopy Irrigation Pump K060962 Olympus Exera 160A videoprocessor K051645 Device Description. 21 CFR… | 2006 |
| * | K051645 | Evis Exera 160A SystemSummary page 2…30854 EndloGatorEndloscopy Irrigation Pump K060962 Olympus Exera 160A videoprocessor K051645 Device Description. 21 CFR 807.92(a)(4): The invendo C20 Colonoscopy System has many features in common with cur… | 2005 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 21 of the 108 ancestors have a recall of any class.
- Of its descendants, K121582 (Invendo Medical Gbmh, 2012) has gone furthest, with 5 descendants of its own.
- 14 other devices also cite its predicate K001241.
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. 2012, 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 invendo C20 Colonoscopy System is intended to provide visualization and
diagnostic / therapeutic access to the adult lower gastrointestinal tract
(including but not limited to, the anus, rectum, sigmoid colon, colon, cecum
an ileocecal valve) for endoscopy and endloscopic surgery.
The colonoscope component of the invendo C20 Colonoscopy System, the
SC20 colonoscope, is a single use disposable device. The SC20 colonoscope
cannot be reprocessed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100624: Invendo C20 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/K100624
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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