# K090205: Bci WW1021 PC Application

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Pm, Inc.
- Decided: Apr 28, 2009 after 90 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 WW1621 Oximetry Data Management Software: named in the summary without a submission number

## Indications for use
WW1021 is intended for use with any oximeter/device which supports the BCI® Communication Protocol 1030 (BCICP 1030), if the device is connected to the PC through the USB port. It can be used to view the data being recorded in real time; download the recorded data to the PC from the device; analyze and print the recorded data and can be used in sleep screening. It can show only visual alarms and cannot annunciate audio alarms. It is not intended to be used as a central station monitoring system or as a patient monitoring system. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, sleep technicians and other qualified health care providers. WW1021 may be used in the hospital or clinical environment.

Source page: https://510kreport.com/device/K090205
Methodology: https://510kreport.com/methodology