# K012974: Prizm Medical Inc. Thermotrace Infrared Thermometer Models 15004 and 15007

- Pathway: 510(k) (Traditional)
- Applicant: Prizm Medical, Inc.
- Decided: Jul 23, 2002 after 321 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) J & J Engineering, Inc. Thermistor Thermometer: named in the summary without a submission number
- (no number) Exergen Corporation DermaTemp DT 1001: named in the summary without a submission number

## Indications for use
The Prizm Medical, Inc. ThermoTraceTMInfrared Thermometer Models 15004 and 15007 are a hand held instrument intended for use in clinical settings for the intermittent measurement and monitoring of skin temperature variations on people of all ages.

Source page: https://510kreport.com/device/K012974
Methodology: https://510kreport.com/methodology