# K121480: Ariatele Telemetry Transmitter (96281)

- Pathway: 510(k) (Special)
- Applicant: Spacelabs Healthcare
- Decided: Jun 6, 2012 after 19 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K933143 (1994). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983996: Spacelabs Medical Ultraview Digital Telemtry System, Spacelabs Medical, Inc. (1999) Summary page 1.

## Recalls of this device
- Jul 2, 2014 · Class II · Z-2586-2014: The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of 
- Dec 19, 2013 · Class II · Z-0871-2014: The AriaTele Model 96281 with SpO2 monitoring Option C is recalled because the AriaTele (transmitter) display and the Telemetry Central Station display may show a SpO2 value when the sensor is not con

## Indications for use
The Spacelabs Healthcare AriaTele Telemetry Transmritter (96281), when used in conjunction with a Spacelabs Healthcare Ultraview patient monitor and telemetry receiver, provides a means for the continuous monitoring of electrocardiographic signals in order to detect abnormal cardiac rhythms, including life-threatening events such as high and low heart rates, asystole, and ventricular fibrillation. Optionally, on adult patients, additional abnormal cardiac rhythms, such as ventricular runs, tachycardia, and ST segment deviations are detected. The 96281 also provides a means for both continuous and episodic monitoring of pulse blood oxygen saturation signals in order to detect desaturation caused by abnormal pulmonary! circulatory functions. The 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

Source page: https://510kreport.com/device/K121480
Methodology: https://510kreport.com/methodology