510(k) · Cleared
Clearedinvendoscopy E200 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invendo Medical GmbH · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Aug 25, 2016 as substantially equivalent to K100624 (Invendo Medical Gbmh, 2012) and 2 other predicates after a 101-day review. Its family tree reaches back 10 generations to 1989. 3 of the 132 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Aug 25, 2016
- Review
- 101 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K894632 (1989). 130 ancestors in all, the oldest K812810 (1981). 1 later device descends from it, 1 citing it directly. 3 of the 132 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 6 generations between
- 3 generations backK092156 Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009
- 2 generations backK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
- 1 generation backK121582 Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012
- This deviceK161355 invendoscopy E200 SystemInvendo Medical GmbH · 2016
- Descendant · cites it directly · 0 of its ownK173085 invendoscopy E210 SystemInvendo Medical GmbH · 2018
Show all 10 generations
- Root · 10 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 9 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 8 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 7 generations backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- 6 generations backK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
- 5 generations backK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
- 4 generations backK063683 Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic…Olympus Medical Systems Corporation · 2007
- 3 generations backK092156 Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009
- 2 generations backK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
- 1 generation backK121582 Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012
- This deviceK161355 invendoscopy E200 SystemInvendo Medical GmbH · 2016
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K173085invendoscopy E210 SystemInvendo Medical GmbH · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −9 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −8 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −7 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −6 | K994096 | Sonoheart Hand-Carried Echocardiography System | Sonosite,Inc. | 1999 | — |
| −5 | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | 2001 | 2 |
| −4 | K063683 | Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic… | Olympus Medical Systems Corporation | 2007 | — |
| −3 | K092156 | Cad 12, Colonoscopy Assist Device | Softscope Medical Technologies, Inc. | 2009 | — |
| −2 | K100624 | Invendo C20 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| −1 | K121582 | Invendo C25 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| 0 (this device) | K161355 | invendoscopy E200 System | Invendo Medical GmbH | 2016 | — |
| +1 | 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 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 4 | 1 |
| 1992 | 6 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 8 | 0 |
| 1996 | 12 | 0 |
| 1997 | 11 | 0 |
| 1998 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 8 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 1 |
| 2004 | 6 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 1 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 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? (3)
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 |
|---|---|---|---|
| * | K100624 | Invendo C20 Colonoscopy SystemSummary page 4…s II (876.1500) / Colonoscope and Accessories, flexible/rigid Product Code FDF Review Panel Gastroenterology/Urology Predicate Devices K100624 invendo C20 Colonoscopy System K121582 invendo C25 Colonoscopy System K100584… | 2012 |
| * | K121582 | Invendo C25 Colonoscopy SystemSummary page 4…id Product Code FDF Review Panel Gastroenterology/Urology Predicate Devices K100624 invendo C20 Colonoscopy System K121582 invendo C25 Colonoscopy System K100584 Olympus EVIS EXERA II 180 SYSTEM… | 2012 |
| * | K100584 | Evis Exeraii 180 SystemSummary page 4…Gastroenterology/Urology Predicate Devices K100624 invendo C20 Colonoscopy System K121582 invendo C25 Colonoscopy System K100584 Olympus EVIS EXERA II 180 SYSTEM… | 2010 |
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 |
|---|---|---|---|
| K173085 | invendoscopy E210 System | 2018 | 0 |
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 · 2 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 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 4 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- 31 of the 130 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K173085 (Invendo Medical GmbH, 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K100624.
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 invendoscopy E200 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 and ileocecal valve) for endoscopy and endoscopic surgery.
The colonoscope component of the invendoscopy E200 System, the invendoscope SC200, is a sterile single use disposable device. The invendoscope SC200 cannot be reprocessed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161355 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161355: invendoscopy E200 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161355
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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