# K081800: T12S Telemetry Transmitter

- Pathway: 510(k) (Abbreviated)
- Applicant: Mortara Instrument, Inc.
- Decided: Sep 24, 2008 after 91 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (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). 22 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974149: Ambulatory X-12 Telemetry Module, Mortara Instrument, Inc. (1998) Summary page 1.
- K000779: Apexpro Telemetry System, General Electric Medical Systems Information Techn (2000) Summary page 1.
- K983996: Spacelabs Medical Ultraview Digital Telemtry System, Spacelabs Medical, Inc. (1999) Summary page 1.

## Cited in the summary but kept off the family tree
- K993516: HP M2600A Viridia Telemetry System, Hewlett-Packard Co. (1999). Our reading of the summary gave K993516, FDA’s number for HP M2600A Viridia Telemetry System (Hewlett-Packard Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Philips Intellivue”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K141020: Surveyor S4 Mobile Monitor (2014), 2 descendants of its own
- K182297: Surveyor S2 (2019), 0 descendants of its own
- K160685: Surveyor S4 Mobile Monitor (2016), 0 descendants of its own

## Recalls of this device
- Mar 18, 2020 · Class II · Z-1813-2020: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

## Indications for use
The T12S Telemetry Transmitter is a non-invasive prescription device indicated for use as a radiofrequency physiological signal transmitter that acquires and delivers RF transmission of real-time electrocardiographic and pulse oximetry data obtained during physiologic stress exercise testing and ambulatory patient monitoring. indicated for use in a clinical setting, by qualified medical professionals, properly trained for ECG monitoring and use of the system. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements. It is not intended as a sole means of diagnosis. The pulse oximetry sensor is indicated for use for continuous or spot monitoring of non-invasive arterial oxygen saturation monitoring. indicated for use on hospital patients of any age where ambulatory monitoring of ECG and SpO2 data is done (e.g. patients in Coronary Care Units, Step-Down Units, Emergency Departments, stress testing or rehabilitation departments). It is not designed for out of hospital transport. It is not designed for use in highly invasive environments, such as an operating theatre. The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

Source page: https://510kreport.com/device/K081800
Methodology: https://510kreport.com/methodology