# K150530: Level Sensor, Level Sensor Tape

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: May 8, 2015 after 67 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
Longest line of descent: 5 generations back to K915183 (1992). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070286: Bio-Console, Model 560, Medtronic (2007) Summary page 5.
- K070213: Performer CBP System, Rand S.R.L. (2007) Summary page 5.

## Indications for use
The Medtronic Bio-Console 560 System with Level Sensing System (Level Sensor [LS100] and Level Sensing Tape [LST]) is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours). The Medtronic Performer CPB System with Level Sensing System (Level Sensor [LS100] and Level Sensing Tape [LST]) is indicated for use up to 6 hours in the extracorporeal circulation of fluids for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Source page: https://510kreport.com/device/K150530
Methodology: https://510kreport.com/methodology