# K963496: Oxi Temp

- Pathway: 510(k) (Traditional)
- Applicant: Bci Intl., Inc.
- Decided: Nov 26, 1996 after 84 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- 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) BCI 3301T OxiTemp: named in the summary without a submission number
- (no number) Exergen OtoTemp: named in the summary without a submission number

## Indications for use
The OxiTemp provides fast, reliable SpO2, pulse rate and temperature measurements. It can be used in the hospital or clinical environment, and during emergency air or land transport. The oximeter will operate accurately over an ambient temperature range of 32 to 110° F (0 to 43° C). The IR ear thermometer uses a patented ambient temperature compensation technique that allows it to provide accurate patient temperatures over the ambient temperature range 60 to 110° F (16 to 43° C). Below 16°C (60°F) a low ambient message is displayed. The oximeter works with all BCI oximetry probes providing SpO2 and pulse rate on all patients from neonate to adult. The IR ear thermometer must seal the ear canal opening and look into the ear canal to provide an accurate temperature measurement. Therefore the adult size temperature probe (3340 series) is restricted to patients over two years of age. The pediatric size temperature probe (3341 series) is restricted to patients over one month of age.

Source page: https://510kreport.com/device/K963496
Methodology: https://510kreport.com/methodology