# K092156: Cad 12, Colonoscopy Assist Device

- Pathway: 510(k) (Traditional)
- Applicant: Softscope Medical Technologies, Inc.
- Decided: Oct 14, 2009 after 90 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K894632 (1989). 64 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052084: Endo-Ease Endoscopic Overtube, Spirus Medical, Inc. (2005) Summary page 1.
- K090116: Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15, Fujinon, Inc. (2009) Summary page 1.
- K970049: BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath Ultra Imaging Catheter 2.9F/20MHZ/37411/, Cardiovascular Imaging Systems, Inc. (1997) Summary page 1.
- K060947: Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020, Boston Scientific Corp (2006) Summary page 1.
- K982610: Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract), Olympus Optical, Co. (1998) Summary page 1.
- K063683: Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic Gastrovideoscope, Olympus Medical Systems Corporation (2007) Summary page 1.

## Most influential descendants
- K100624: Invendo C20 Colonoscopy System (2012), 6 descendants of its own
- K121582: Invendo C25 Colonoscopy System (2012), 5 descendants of its own
- K141286: Aer-O-Scope Colonoscope System (2014), 2 descendants of its own
- K161355: invendoscopy E200 System (2016), 1 descendant of its own
- K190669: Endotics (2020), 0 descendants of its own

## Indications for use
The CAD 12 is indicated for use with a flexible endoscope to aid endoscopic insertion and advancement during diagnostic and therapeutic lower gastrointestinal endoscopy.

Source page: https://510kreport.com/device/K092156
Methodology: https://510kreport.com/methodology