# K961404: MX960 Reusable Pressure Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Medex, Inc.
- Decided: Jun 27, 1996 after 77 days
- Product code: DRS (Transducer, Blood-Pressure, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2850
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951129 (1995). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951129: Novatrans II, Medex, Inc. (1995) Summary page 1.

## Most influential descendants
- K221782: Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes (2023), 0 descendants of its own
- K981745: Biotrans Reusable Sensor Base Model Number BT Xxxxxx (1998), 0 descendants of its own

## Recalls of this device
- Mar 31, 2021 · Class II · Z-1471-2021: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components f
- Mar 31, 2021 · Class II · Z-1470-2021: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components f
- Mar 31, 2021 · Class II · Z-1474-2021: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components f
- Mar 31, 2021 · Class II · Z-1473-2021: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components f
- Mar 31, 2021 · Class II · Z-1477-2021: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components f

## Indications for use
The MX960 reusable pressure transducer is used to convert hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals which can then be displayed using separate monitoring equipment.

Source page: https://510kreport.com/device/K961404
Methodology: https://510kreport.com/methodology