510(k) · Cleared
ClearedAer-O-Scope Colonoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gi View, Ltd. · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Aug 11, 2016 as substantially equivalent to K100624 (Invendo Medical Gbmh, 2012) and 2 other predicates after a 43-day review. Its family tree reaches back 11 generations to 1989.
- Decided
- Aug 11, 2016
- Review
- 43 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K894632 (1989). 111 ancestors in all, the oldest K812810 (1981). No later device cites it as a predicate yet.
- Root · 11 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 7 generations between
- 3 generations backK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
- 2 generations backK121582 Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012
- 1 generation backK141286 Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2014
- This deviceK161791 Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2016
Show all 11 generations
- Root · 11 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 10 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 9 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 8 generations backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- 7 generations backK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
- 6 generations backK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
- 5 generations backK063683 Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic…Olympus Medical Systems Corporation · 2007
- 4 generations backK092156 Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009
- 3 generations backK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
- 2 generations backK121582 Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012
- 1 generation backK141286 Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2014
- This deviceK161791 Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −10 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −9 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −8 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −7 | K994096 | Sonoheart Hand-Carried Echocardiography System | Sonosite,Inc. | 1999 | — |
| −6 | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | 2001 | 2 |
| −5 | K063683 | Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic… | Olympus Medical Systems Corporation | 2007 | — |
| −4 | K092156 | Cad 12, Colonoscopy Assist Device | Softscope Medical Technologies, Inc. | 2009 | — |
| −3 | K100624 | Invendo C20 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| −2 | K121582 | Invendo C25 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| −1 | K141286 | Aer-O-Scope Colonoscope System | Gi View, Ltd. | 2014 | — |
| 0 (this device) | K161791 | Aer-O-Scope Colonoscope System | Gi View, Ltd. | 2016 | — |
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 |
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? (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…accessories, 21 CFR § 876.1500 Product Code: FDF Predicate Device, 21 CFR 807.92(a)(3): Trade Name: Invendo C20 Colonoscopy System 510(k) Number: K100624 and K121582 Common Name: Colonoscope Classification Name: Endoscope and accessories, 21CFR 876.1500 Product Code: FDF… | 2012 |
| * | K121582 | Invendo C25 Colonoscopy SystemSummary page 4…, 21 CFR § 876.1500 Product Code: FDF Predicate Device, 21 CFR 807.92(a)(3): Trade Name: Invendo C20 Colonoscopy System 510(k) Number: K100624 and K121582 Common Name: Colonoscope Classification Name: Endoscope and accessories, 21CFR 876.1500 Product Code: FDF Predicat… | 2012 |
| * | K141286 | Aer-O-Scope Colonoscope SystemSummary page 4…ope and accessories, 21CFR 876.1500 Product Code: FDF Predicate Device, 21 CFR 807.92(a)(3): Trade Name: Aer-O-Scope Colonoscope System 510(k) Number: K141286 Page VII-2 .… | 2014 |
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 27 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 21 of the 111 ancestors have a recall of any class.
- 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 Aer-O-Scope Colonoscope System is intended to provide panoramic (360o) visualization (via a video monitor) and
diagnostic/therapeutic access to the adult lower gastrointestinal tract, (including but not limited to, the anus, rectum,
sigmoid colon, transverse colon, cecum and ileocecal valve) for endoscopy.
The Aer-O-Scope Disposable Scanner (colonoscope component of the Aer-O-Scope Colonoscope System) is a single use
disposable device. An Aer-O-Scope Scanner cannot be reprocessed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161791 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161791: Aer-O-Scope Colonoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161791
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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