# K971455: Clarus Model 5197 Sightlite

- Pathway: 510(k) (Traditional)
- Applicant: Clarus Medical Systems, Inc.
- Decided: May 20, 1997 after 29 days
- Product code: FTI (Lamp, Endoscope, Incandescent)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) RapiScope™ Manual Light Source, manufactured by Cook Critical Care: named in the summary without a submission number

## Most influential descendants
- K990397: Flexible Fiberscopes & Accessories (1999), 0 descendants of its own

## Indications for use
Illumination source for Clarus endoscopes.

Source page: https://510kreport.com/device/K971455
Methodology: https://510kreport.com/methodology