# K092950: Solaris Models NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories

- Pathway: 510(k) (Special)
- Applicant: Solaris Medical Technology, Inc.
- Decided: Mar 12, 2010 after 169 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 K001688 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073249: Solaris NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories, Solaris Medical Technology, Inc. (2008) Summary page 2.

## Indications for use
The Solaris NT1 Handheld Pulse Oximeter with Sensor Accessories is a non-invasive spot-check, functional arterial oxygen saturation and pulse rate monitor. The device operates on battery power using SOLARIS reusable SpO2 sensors. The device is intended for pediatric and adult patients and can be used in hospital clinical areas by medical and nursing staff. The Solaris NT1A Handheld Pulse Oximeter with Sensor Accessories is a non-invasive spot-check or continuous monitoring, functional arterial oxygen saturation and pulse rate monitor. The device has data storage and data transfer functionality via a USB hub. The device operates on battery power using SOLARIS reusable SpO2 sensors. The device is intended for pediatric and adult patients and can be used in hospital clinical areas by medical and nursing staff.

Source page: https://510kreport.com/device/K092950
Methodology: https://510kreport.com/methodology