# K221782: Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Pte., Ltd.
- Decided: Mar 17, 2023 after 269 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: 3 generations back to K885281 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961404: MX960 Reusable Pressure Transducer, Medex, Inc. (1996) Summary page 4.
- K172458: HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit, Smiths Medical Asd, Inc. (2017) Summary page 4.

## Indications for use
The Meritrans ECO Reusable Pressure Transducer is intended to be coupled with a disposable dome kit for converting hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals for invasive blood pressure monitoring when connected to a patient monitor or recording device. The devices are intended for pediatric and adult patient populations.

Source page: https://510kreport.com/device/K221782
Methodology: https://510kreport.com/methodology