# K013862: Bci 1621 Oximetry Data Management Program

- Pathway: 510(k) (Traditional)
- Applicant: Bci, Inc.
- Decided: Feb 21, 2002 after 92 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
Longest line of descent: 2 generations back to K913695 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011156: Bci 3403 Sleep Screening Pulse Oximeter, Bci, Inc. (2001) Summary page 1.
- K961450: Score Software, Nellcor Puritan Bennett, Inc. (1996) Summary page 1.

## Indications for use
The BCI 1621 Oximetry Data Management Program analyzes data recorded using the BCI 3403 pulse oximeter and provides a printed oximetry data analysis report and graphical SpO; trend. This information can aid in the analysis of pulse oximetry data. Data from the BCI 3403 pulse oximeter are downloaded for analysis using a unique cable.

Source page: https://510kreport.com/device/K013862
Methodology: https://510kreport.com/methodology