# K852232: Pressure Display Box #60000/Tubing Set #61000

- Pathway: 510(k) (Traditional)
- Applicant: Dlp, Inc.
- Decided: Aug 9, 1985 after 79 days
- Product code: DXS (Gauge, Pressure, Coronary, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4310
- Recalls of this device: 4 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K113235: Pressure Display Box,DLP Disposable Pressure Display Sets-Non Sterile Versions (2011), 0 descendants of its own

## Recalls of this device
- Jun 22, 2017 · Class II · Z-2768-2017: Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
- Sep 9, 2011 · Not classified · Z-0078-2012: Pressure Display Set (models 61000, 61006, 62000, 62006) DFU will be updated to clarify that the intended use of the disposables is only for cardiopulmonary bypass surgery (procedures up to 6 hours). 
- Sep 9, 2011 · Not classified · Z-0077-2012: The DFU for the Medtronic Pressure Display Box, model 66000, states that, for display readings of -100 to +300 mmHg there will be an accuracy of +/-5 mmHg, and for display readings of +301 to +500 mmH
- Sep 9, 2011 · Not classified · Z-0079-2012: Pressure Display Set (models 61000, 61006, 62000, 62006) DFU will be updated to clarify that the intended use of the disposables is only for cardiopulmonary bypass surgery (procedures up to 6 hours). 

Source page: https://510kreport.com/device/K852232
Methodology: https://510kreport.com/methodology