# K970686: Accutemp-Probe

- Pathway: 510(k) (Traditional)
- Applicant: Kentec Medical, Inc.
- Decided: Aug 25, 1997 after 181 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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) Air Shields/Ohmeda: named in the summary without a submission number

## Most influential descendants
- K020219: Rpi Skin or Air Temperature Probe (2002), 1 descendant of its own
- K071977: Tarry Medical Temperature Probes (2008), 0 descendants of its own

## Indications for use
There are two modes of operation for temperature control in incubators and infant warmers where these products are used, air or manual mode and baby or skin temperature control mode. When operating in the air or manual mode, a skin temperature probe may be used just to monitor the patient's skin temperature. Here, a nurse would control the heater output manually. When operating in the "Baby" or "Skin Temperature Control Mode" the warming units controller utilizes the skin temperature probe, connected between the controller and the infant, to automatically adjust the heater output of the unit to maintain a pre-selected skin temperature.

Source page: https://510kreport.com/device/K970686
Methodology: https://510kreport.com/methodology