# K831506: Disp. Transducer W/Monitoring Kit Trans

- Pathway: 510(k) (Traditional)
- Applicant: Sorensen Research
- Decided: Aug 12, 1983 after 93 days
- Product code: DRS (Transducer, Blood-Pressure, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2850
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
23 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K052828: Disposable Transpac Iii Integrated Transducer (IT) (2006), 22 descendants of its own
- 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

## Recalls of this device
- Nov 27, 2018 · Class II · Z-1072-2019: 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
- Jan 9, 2006 · Not classified · Z-0506-06: The I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market.

Source page: https://510kreport.com/device/K831506
Methodology: https://510kreport.com/methodology