# K152905: ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Arc Devices Limited
- Decided: Jul 20, 2016 after 293 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
Longest line of descent: 1 generation back to K090361 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090361: Remote Infrared Thermometer, Model RC002, Rycom Electron Technology Limited (2009) Summary page 5.

## Indications for use
The ARC InstaTemp™ is an infrared thermometer that measures temperature from the forehead in both infants and adults without contacting the human body. The ARC InstaTemp MD™ is an infrared thermometer that measures temperature from the forehead in both infants and adults without contacting the human body. It is intended for use by a Health Care Professional in a clinical environment. This device is not intended for home use.

Source page: https://510kreport.com/device/K152905
Methodology: https://510kreport.com/methodology