# K992857: Levelsens - Flexible, Model 201110, Levelsens - Rigid, Model 201070

- Pathway: 510(k) (Traditional)
- Applicant: Rocky Mountain Research, Inc.
- Decided: Nov 10, 1999 after 77 days
- Product code: DTW (Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4340
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The LevelSens is an accessory safety device which monitors blood or saline levels in a reservoir and sounds an alarm when the level falls below a predetermined level. It is currently configured for intended use with either Rigid Polycarbonate or Flexible Polyvinyl chloride (PVC) reservoirs.

Source page: https://510kreport.com/device/K992857
Methodology: https://510kreport.com/methodology