Pressure Display Box #60000/Tubing Set #61000

510(k) K852232

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK852232	Date9 Aug 1985Cleared	StatusActive

4 recalls · FDA

- Terminated Z-2768-2017 FDA Class II initiated 22 Jun 2017
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
2 recalls, same reason
- Terminated Z-0079-2012 FDA Unclassified (pre-2012) initiated 9 Sep 2011
- Terminated Z-0078-2012 FDA Unclassified (pre-2012) initiated 9 Sep 2011
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). Use beyond 6 hours may result in air leakage in the system resulting in a pressure reading that is not representative of the actual line pressure.
- Terminated Z-0077-2012 FDA Unclassified (pre-2012) initiated 9 Sep 2011
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 mmHg there will be an accuracy of +/-10 mmHg. Through reports from customers, Medtronic has become aware that the Pressure Display Box may not always accurately display readings. During use in the -40

1 jurisdiction

United States — FDA 510(k) Active

510(k)