# K972314: Paratrend 7 Neotrend Multiparameter/Sensor with Paratrend 7 Multiparameter Senior and Satellite Monitor System

- Pathway: 510(k) (Traditional)
- Applicant: Diametrics Medical, Ltd.
- Decided: Dec 19, 1997 after 182 days
- Product code: CCC (Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling)
- Device class: 2
- Regulation: 21 CFR 868.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Paratrend 7 Intravascular Blood Gas Monitoring System: named in the summary without a submission number
- (no number) Paratrend 7 Satellite Multiparameter Blood Gas Monitoring System: named in the summary without a submission number
- (no number) Optex Blood Gas Monitoring System: named in the summary without a submission number
- (no number) Neocath 1000 Umbilical Artery Oxygen Monitoring System: named in the summary without a submission number

## Most influential descendants
- K071013: Redsense (2007), 3 descendants of its own
- K092955: Redsense-Home Use (2010), 2 descendants of its own
- K103242: Redsense-Alarm Unit and Sensor (2011), 1 descendant of its own
- K130554: Redsense Alarm System (2013), 0 descendants of its own

## Indications for use
The Neotrend Multiparameter Sensor is inserted via an intravascular access device into the vascular system, e.g. umbilical artery (neonates), femoral artery (paediatrics, adults). It is intended to be used in the management of critically ill patients of any age, but especially neonates, by providing continuous blood gas data while permitting the simultaneous monitoring of blood pressure via an external transducer. The Neotrend sensor is designed for use in conjunction only with the custom umbilical artery catheter supplied when the umbilical artery is to be the access site. The sensor is used in conjunction with the Paratrend 7 Multiparameter Senior and/or Satellite Monitor systems. Completion of Monitoring and Sensor Withdrawal Within the United States market, the use of this device should be limited to 72 hours.

Source page: https://510kreport.com/device/K972314
Methodology: https://510kreport.com/methodology