# K993358: Sightsure Operation Indicator, Model SS301

- Pathway: 510(k) (Traditional)
- Applicant: Medevices, Inc.
- Decided: Mar 15, 2000 after 161 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Nasal Flowmeter: named in the summary without a submission number
- (no number) Thrope Tube Flowmeter: named in the summary without a submission number

## Indications for use
The SightSure® Operation Indicator is indicated for use as an accessory to a dual lumen gastrointestinal sump tube with an air vent lumen which allows for a visual monitor of proper functioning of the tube during medical use.

Source page: https://510kreport.com/device/K993358
Methodology: https://510kreport.com/methodology