# K822846: Pentax FC-38LA & FC-38SA Colonofiber

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Oct 22, 1982 after 29 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- 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
No predicates in its family tree.
76 later devices descend from it; 2 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K951574: EC-3800L, Video Colonoscope (1996), 72 descendants of its own
- K951579: EC-3800TL, Video Colonoscope (1996), 42 descendants of its own
- K961570: Kec-3840L/F, Video Colonoscope (*L or F in Model Number Denotes Length) (1996), 39 descendants of its own
- K961563: EC-384OTL, Video Colonscope (1996), 39 descendants of its own
- K032688: Colonosight Model 510B (2004), 38 descendants of its own

Source page: https://510kreport.com/device/K822846
Methodology: https://510kreport.com/methodology