# K061573: Transpac Iii Disposable Straight Pressure Transducer and Kit - Pathway: 510(k) (Special) - Applicant: Hospira, Inc. - Decided: Sep 19, 2006 after 104 days - Product code: DRS (Transducer, Blood-Pressure, Extravascular) - Device class: 2 - Regulation: 21 CFR 870.2850 - Recalls of this device: 193 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 2 generations back to K831506 (1983). 3 ancestors in all. 20 later devices descend from it; 5 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) - K884823: Transpac (R) II, Disposable Transducer, Abbott Laboratories (1990) Summary page 2. - K052828: Disposable Transpac Iii Integrated Transducer (IT), Hospira, Inc. (2006) Summary page 2. ## Most influential descendants - 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 - K182979: IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 (2019), 5 descendants of its own ## Recalls of this device - Sep 27, 2016 · Class II · Z-0449-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0450-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0429-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0438-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0452-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0422-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0461-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0440-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0453-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0456-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0437-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0465-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0420-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0446-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0435-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0439-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0425-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0443-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0426-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0468-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0448-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0451-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0430-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0462-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0463-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0427-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0466-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0416-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0415-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0432-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0444-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0421-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0447-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0424-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0434-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0423-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0460-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0436-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0442-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0428-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0445-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0418-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0467-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0433-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0441-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0417-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0419-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0431-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0464-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. - Sep 27, 2016 · Class II · Z-0414-2017: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. ## Indications for use The Transpac® III Disposable Straight Pressure Transducer (DSPT) is intended for direct measurement and monitoring of fluid pressure. Indications for the Transpac® III DSPT include: Intracranial Pressure Monitoring, Intrauterine Pressure Monitoring, or Compartmental (Intramuscular) Pressure Monitoring. In addition, indications for the Transpac® III DSPT include: 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 catheterization. Source page: https://510kreport.com/device/K061573 Methodology: https://510kreport.com/methodology