# K052828: Disposable Transpac Iii Integrated Transducer (IT)

- Pathway: 510(k) (Special)
- Applicant: Hospira, Inc.
- Decided: Feb 17, 2006 after 135 days
- Product code: DRS (Transducer, Blood-Pressure, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2850
- 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 K831506 (1983). 1 ancestor in all.
22 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831506: Disp. Transducer W/Monitoring Kit Trans, Sorensen Research (1983) Summary page 2.

## Most influential descendants
- K061573: Transpac Iii Disposable Straight Pressure Transducer and Kit (2006), 20 descendants of its own
- K171801: IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable (2017), 8 descendants of its own
- K091408: Disposable Pressure Transducer (2009), 7 descendants of its own
- K181314: IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension (2018), 6 descendants of its own
- K101518: Compass Vascular Access; Compass Lumbar Puncture (2010), 6 descendants of its own

## Recalls of this device
- Nov 27, 2018 · Class II · Z-1071-2019: Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in r

## Indications for use
The Disposable Transpac® III Integrated Transducer (IT) is intended for direct measurement and monitoring of blood pressure. The Transpac® IllIT is intended for one-time use. Indications for the Disposable Transpac® III ITinclude: Direct arterial blood pressure monitoring - central and peripheral, Pulmonary artery monitoring, Venous pressure monitoring, Left atrial monitoring when used with an air eliminator filter, and Cardiac cathterization.

Source page: https://510kreport.com/device/K052828
Methodology: https://510kreport.com/methodology