510(k) · Cleared
ClearedCad 12, Colonoscopy Assist Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Softscope Medical Technologies, Inc. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Oct 14, 2009 as substantially equivalent to K052084 (Spirus Medical, Inc., 2005) and 5 other predicates after a 90-day review. Its family tree reaches back 7 generations to 1989. 7 later devices descend from it.
- Decided
- Oct 14, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K894632 (1989). 64 ancestors in all, the oldest K812810 (1981). 7 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 6 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 5 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 4 generations backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- 3 generations backK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
- 2 generations backK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
- 1 generation backK063683 Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic…Olympus Medical Systems Corporation · 2007
- This deviceK092156 Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009
- Descendant · cites it directly · 6 of its ownK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
- Descendant · 2 generations on · 5 of its ownK121582 Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012
- Descendant · 2 generations on · 2 of its ownK141286 Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK161355 invendoscopy E200 SystemInvendo Medical GmbH · 2016
- Descendant · 3 generations on · 0 of its ownK190669 EndoticsEra Endoscopy S.R.L. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012 · cites it directly6descendants
- K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 2 generations on5descendants
- K141286Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2014 · 2 generations on2descendants
- K161355invendoscopy E200 SystemInvendo Medical GmbH · 2016 · 2 generations on1descendant
- K190669EndoticsEra Endoscopy S.R.L. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −6 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −5 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −4 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −3 | K994096 | Sonoheart Hand-Carried Echocardiography System | Sonosite,Inc. | 1999 | — |
| −2 | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | 2001 | 2 |
| −1 | K063683 | Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic… | Olympus Medical Systems Corporation | 2007 | — |
| 0 (this device) | K092156 | Cad 12, Colonoscopy Assist Device | Softscope Medical Technologies, Inc. | 2009 | — |
| +1 | K100624 | Invendo C20 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +2 | K121582 | Invendo C25 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +2 | K141286 | Aer-O-Scope Colonoscope System | Gi View, Ltd. | 2014 | — |
| +2 | K161355 | invendoscopy E200 System | Invendo Medical GmbH | 2016 | — |
| +3 | K190669 | Endotics | Era Endoscopy S.R.L. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 11 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 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 FED? 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 FED device
- #1 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K052084 | Endo-Ease Endoscopic OvertubeSummary page 1…is substantially equivalent to the following predicate devices: Intended Use and Device Design: $ Spirus Medical Endo-Ease Overtube, K052084 * Fujinon EC-450 Double Balloon Overtube, K090116 Rotating Drive Mechanism:… | 2005 |
| * | K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15Summary page 1…Intended Use and Device Design: $ Spirus Medical Endo-Ease Overtube, K052084 * Fujinon EC-450 Double Balloon Overtube, K090116 Rotating Drive Mechanism: * Boston Scientific Sonicath Ultrasonic Catheter, K970049/K060947… | 2009 |
| * | K970049 | BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath Ultra…Summary page 1…* Fujinon EC-450 Double Balloon Overtube, K090116 Rotating Drive Mechanism: * Boston Scientific Sonicath Ultrasonic Catheter, K970049/K060947 · Olympus Ultrasonic Transducer, K982610/K063683 3. Description of the Device The CAD 12 is a… | 1997 |
| * | K060947 | Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020Summary page 1…* Fujinon EC-450 Double Balloon Overtube, K090116 Rotating Drive Mechanism: * Boston Scientific Sonicath Ultrasonic Catheter, K970049/K060947 · Olympus Ultrasonic Transducer, K982610/K063683 3. Description of the Device The CAD 12 is an endosc… | 2006 |
| * | K982610 | Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract)Summary page 1…Rotating Drive Mechanism: * Boston Scientific Sonicath Ultrasonic Catheter, K970049/K060947 · Olympus Ultrasonic Transducer, K982610/K063683 3. Description of the Device The CAD 12 is an endoscopic accessory device configured as an overtube to aid insert… | 1998 |
| * | K063683 | Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeSummary page 1…ating Drive Mechanism: * Boston Scientific Sonicath Ultrasonic Catheter, K970049/K060947 · Olympus Ultrasonic Transducer, K982610/K063683 3. Description of the Device The CAD 12 is an endoscopic accessory device configured as an overtube to aid insertion… | 2007 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100624 | Invendo C20 Colonoscopy System | 2012 | 6 |
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 20 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 13 of the 64 ancestors have a recall of any class.
- Of its descendants, K100624 (Invendo Medical Gbmh, 2012) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K052084.
How does its category compare?
All FED devicesFED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FED
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FED
120in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FED
4in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · FED
115in 2025
MAUDE reports naming product code FED, 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 | 1 | — | 1 | 14 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 4 | 90 | 0 | 19 |
| 2010 | 3 | 90 | 0 | 19 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 4 | 82 | 0 | 35 |
| 2013 | 2 | — | 3 | 25 |
| 2014 | 4 | 123 | 0 | 34 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 5 | 126 | 0 | 29 |
| 2017 | 1 | — | 0 | 32 |
| 2018 | 4 | 122 | 0 | 34 |
| 2019 | 5 | 94 | 0 | 30 |
| 2020 | 4 | 117 | 0 | 33 |
| 2021 | 3 | 189 | 0 | 55 |
| 2022 | 1 | — | 0 | 36 |
| 2023 | 3 | 138 | 0 | 53 |
| 2024 | 6 | 98 | 4 (4) | 64 |
| 2025 | 11 | 120 | 0 | 115 |
| 2026 | 6 | 67 | 0 | — |
What is it indicated for?
The CAD 12 is indicated for use with a flexible endoscope to aid endoscopic insertion and advancement during diagnostic and therapeutic lower gastrointestinal endoscopy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092156: Cad 12, Colonoscopy Assist Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092156
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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