# K974697: Reusable Finger Sensor 3444

- Pathway: 510(k) (Traditional)
- Applicant: Bci Intl., Inc.
- Decided: Mar 11, 1998 after 85 days
- Product code: DQH (Cardiograph, Apex (Vibrocardiograph))
- Device class: 2
- Regulation: 21 CFR 870.2310
- 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 3044 Reusable Finger Sensor: named in the summary without a submission number

## Indications for use
The 3444 Reusable Finger Sensor is used with BCI oximetry to noninvasively measure oxygen saturation (SpO₂), pulse rate and plethysmographic pulse waves. The 3444 sensor is recommended for patients weighing more than 15 kg and patients with limited activity. The 3444 Reusable Finger Sensor is not recommended for prolonged use unless skin integrity is checked frequently and the measurement site is changed accordingly. The Reusable Finger Sensor is for use with BCI International monitors and with monitors that contain BCI International oximetry or are licensed to use BCI International sensors.

Source page: https://510kreport.com/device/K974697
Methodology: https://510kreport.com/methodology