# K113235: Pressure Display Box,DLP Disposable Pressure Display Sets-Non Sterile Versions

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Dec 2, 2011 after 30 days
- Product code: DXS (Gauge, Pressure, Coronary, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K852232 (1985). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852232: Pressure Display Box #60000/Tubing Set #61000, Dlp, Inc. (1985) Summary page 1.

## Recalls of this device
- Mar 19, 2024 · Class II · Z-1802-2024: Potential for unsealed sterile packing.

## Indications for use
This product is intended for use in displaying line pressures during cardiopulmonary bypass surgery. This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.

Source page: https://510kreport.com/device/K113235
Methodology: https://510kreport.com/methodology