# K884823: Transpac (R) II, Disposable Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jul 3, 1990 after 592 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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 2, 2004 · Not classified · Z-0618-05: Syringes could possibly allow air to enter the patient's vascular system.
- Nov 2, 2004 · Not classified · Z-0619-05: Syringes could possibly allow air to enter the patient's vascular system.
- Nov 2, 2004 · Not classified · Z-0620-05: Syringes could possibly allow air to enter the patient's vascular system.
- Nov 2, 2004 · Not classified · Z-0617-05: Syringes could possibly allow air to enter the patient's vascular system.

Source page: https://510kreport.com/device/K884823
Methodology: https://510kreport.com/methodology