# K120624: Elcam Disposable Integrated Pressure Transducer (Dipt)

- Pathway: 510(k) (Traditional)
- Applicant: Elcam Medical Acal
- Decided: Jun 8, 2012 after 99 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: 2 generations back to K831506 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052828: Disposable Transpac Iii Integrated Transducer (IT), Hospira, Inc. (2006) Summary page 1.

## Indications for use
Elcam Disposable Integrated Pressure Transducer is intended for direct measurement and monitoring of blood pressure. The disposable Transducer is intended for single use only. Indications for the Disposable Integrated Pressure Transducer (DIPT) include: - Direct arterial blood pressure monitoring - central and peripheral - Pulmonary artery monitoring - Venous pressure monitoring - Left atrial monitoring when used with an air eliminator - Cardiac catheterization

Source page: https://510kreport.com/device/K120624
Methodology: https://510kreport.com/methodology