# K092644: Terumo Pressure Isolator

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Dec 10, 2009 after 105 days
- Product code: DRS (Transducer, Blood-Pressure, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K841959 (1984). 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)
- K841959: Cardio Metric Custom Perfusion Tubing, Sterile Design, Inc. (1984) Summary page 2.

## Indications for use
The pressure isolator is a single use, disposable device that is intended to act as an interface between the extracorporeal circuit and a pressure gauge in order to prevent fluids from coming into contact with gauges while transducing pressure during cardiopulmonary bypass procedures. The device may be used in procedures lasting up to 6 hours in duration.

Source page: https://510kreport.com/device/K092644
Methodology: https://510kreport.com/methodology