# K970011: Escort II Clinical Thermometry Module (CTM)

- Pathway: 510(k) (Traditional)
- Applicant: Medical Data Electronics
- Decided: Jul 9, 1997 after 188 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) ESCORT II Patient Monitor with Yellow Springs Instruments (YSI) temperature measurement capability: named in the summary without a submission number
- (no number) Diatek SureTemp Thermometer System: named in the summary without a submission number
- (no number) Welch Allyn LifeSign Critical Vital Signs Monitor (CVSM): named in the summary without a submission number

## Indications for use
The primary use of the CTM, as an intermittent thermometer, is to take a patient's temperature at a single point in time. However, the instrument's Monitor mode also allows continuous monitoring of the patient's temperature. The CTM is a clinical grade thermometer. It is intended for use by healthcare practitioners only; typically in a hospital, clinic or mobile environment. It is not intended for lay or home use.

Source page: https://510kreport.com/device/K970011
Methodology: https://510kreport.com/methodology