# K960058: Oxitemp, 3301T SA

- Pathway: 510(k) (Traditional)
- Applicant: Bci Intl., Inc.
- Decided: May 15, 1996 after 134 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 3301 T OxiTemp provides fast, reliable SpO2, pulse rate and temperature measurements. It can be used in the hoapital or clinical enviromment, and during emergency sir 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 & patented ambient temperature compensation technique that allows it to provide accurate patiest tamperatures over the ambient temperature rangs 60 to 110° F (16 40 43° C). Below 16°C (60°F) a low ambient message is displayed. The 3301T SA OxiTemp extonds the ambient temperature range the device can operats in up to 130°F (54°C) and down to 32°F (0°C). ‘The oximeter works with all BCT oximetry providing SpO2 and pulse rate on all patients from neonate to aduk (see the section THE PROBE under USING THE OXIMETER in the operations manual). For the 3301T the IR ear thermometer must seal the car canal opening and look into the ear canal t3 provide an accurate temperature measurement. Therefore, it is restricted to patients over two years of age. The 3301T SA provides tympanic temperature measurements. The probe must be able to fit into the ear canal for proper operation. Therefore, it is restricted to patients over three years of age.

Source page: https://510kreport.com/device/K960058
Methodology: https://510kreport.com/methodology