# K964851: Entracare Thermomter Model 1000

- Pathway: 510(k) (Traditional)
- Applicant: Entracare Corp.
- Decided: Feb 3, 1997 after 62 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 K833568 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860436: Ivac Model 2080 Electronic Thermometer, Y (1986) Summary page 1.
- K833568: Diatek 600 Thermometer System, Diatek, Inc. (1984) Summary page 1.

## Indications for use
The EntraCare Thermometer, Model 1000, is intended to be used under a physicians orders when an accurate temperature measurement is required. The device is intended to be used orally or rectally in the human body temperature range of 92°F to 108°F. It may be used with infants, children, or adults in all settings under the order of a physcian. The heart rate timer is also provided to aid in establishing a patients approximate heart rate.

Source page: https://510kreport.com/device/K964851
Methodology: https://510kreport.com/methodology