# K083079: Quanta Pulse Oximeter, Model: Pulse Link 1000 or QH100

- Pathway: 510(k) (Traditional)
- Applicant: Quanta Computer, Inc.
- Decided: Mar 5, 2009 after 140 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: 7 generations back to K962603 (1997). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050056: Model 2500A Palmsat Pulse Oximeter, Nonin Medical, Inc. (2005) Summary page 2.
- K051352: Oximax NPB-40 Handheld Pulse Oximeter, Nellcor Puritan Bennett, Inc. (2005) Summary page 2.

## Indications for use
The Quanta Pulse Oximeter, Model no. Pulse Link 1000 (or QH 100) is a handheld pulse oximeter with alarm. It is intended to be used by trained healthcare professionals in hospital, hospital type facilities, as well as in the home care environment. The Pulse Link 1000 Pulse Oximeter is indicated for non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of patients on fingers (forefinger or middle finger). The Pulse Link 1000 Pulse Oximeter is re-useable. It is indicated for adult patients under no-motion conditions.

Source page: https://510kreport.com/device/K083079
Methodology: https://510kreport.com/methodology