# K083557: Bci WW1030 Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Pm, Inc.
- Decided: May 1, 2009 after 150 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: 3 generations back to K000126 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040214: Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables, Masimo Corp. (2004) Summary page 1.
- K070732: Bci Autocon 3304 Digital Pulse Oximeter, Smiths Medical Pm, Inc. (2007) Summary page 1.
- K991410: 3402 Handheld Pulse Oximeter, Bci Intl., Inc. (1999) Summary page 1.

## Indications for use
The BCI® Model WW1030 pulse oximeter is intended to be used for continuous monitoring of a patient's functional oxygen saturation (%Sp0 2), pulse rate, pulse signal strength, and pulse amplitude index readings. It is equipped with audible and visual alarms. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians, clinicians and home use. The intended patient population ranges from neonatal to adult. It can be used on patients with low perfusion or during patient motion. The WW 1030 may be used in the hospital or clinical environment, during emergency land transport, and the home.

Source page: https://510kreport.com/device/K083557
Methodology: https://510kreport.com/methodology