# K083705: Bci WW1020 Pulse Oximeter, Model WW1020

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Pm, Inc.
- Decided: Apr 9, 2009 after 115 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.
25 later devices descend from it; 3 cite it directly.
0 of 33 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.

## Most influential descendants
- K100077: Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103 (2010), 22 descendants of its own
- K142832: Unimed Disposable and Reusable SPO2 Sensors (2015), 14 descendants of its own
- K153184: Caremed Reusable & Disposable SPO2 Sensors (2017), 5 descendants of its own
- K242580: Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) (2025), 1 descendant of its own
- K202851: Spo2 Sensor (2020), 1 descendant of its own

## Indications for use
The BCI® model WW1020 pulse oximeter is intended for spot-checking applications (non-continuous use). It monitors and displays a patient's functional oxygen saturation (%SpO2), pulse rate, pulse signal strength, and pulse amplitude index readings. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians, clinicians and home users. The intended patient population ranges from neonatal to adult: It can be used on patients with low perfusion or during patient motion. The WW1020 may be used in the hospital or clinical environment, during emergency land transport, and in the home.

Source page: https://510kreport.com/device/K083705
Methodology: https://510kreport.com/methodology