# K981939: Autocorr Plus; 3404 Oximeter/Ecg Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Bci Intl., Inc.
- Decided: Aug 20, 1998 after 79 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) BCI 3304 Pulse Oximeter: named in the summary without a submission number
- (no number) BCI 3100 Oximeter / ECG Monitor: named in the summary without a submission number
- (no number) Siemens SC6000 Bedside Monitor: named in the summary without a submission number

## Most influential descendants
- K023370: Cheetah I.V.D.S., Model 2002P (2002), 0 descendants of its own

## Recalls of this device
- Jul 18, 2007 · Not classified · Z-1240-2007: Phantom pacer spikes caused by a damaged resistor.
- Nov 6, 2006 · Not classified · Z-0300-2007: An error occurred at the board manufacturing site which may affect the following parameters: - An electrical noise observed on the SpO2 pleth waveform generating and displaying erratic heart rates. % 

## Indications for use
The BCI 3404 Monitor is a portable ECG and oximetry monitor with optional impedance respiration. It continuously and non-invasively monitors and displays functional oxygen saturation of arterial hemoglobin(SpO,), pulse rate, respiration rate, plethysmogram and ECG waveforms. Alarms are available for ECG and oximetry. There are no respiration rate alarms. The 3404 may be used in the hospital or clinical environment, and during emergency land transport. The device will provide fast, reliable measurements on patients ranging from pediatric to adult when using the appropriate BCI accessories. The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor. The monitor is not intended for neonatal use.

Source page: https://510kreport.com/device/K981939
Methodology: https://510kreport.com/methodology