# K073249: Solaris NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Solaris Medical Technology, Inc.
- Decided: Jul 25, 2008 after 249 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: 1 generation back to K001688 (2000). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001688: Datex-Ohmeda Tuffsat 3000 Pulse Oximeter, Datex-Ohmeda, Inc. (2000) Summary page 4.

## Most influential descendants
- K123797: NT1D Vital Signs Monitor (2013), 0 descendants of its own
- K092950: Solaris Models NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories (2010), 0 descendants of its own

## Indications for use
Solaris NT1 and NT1A Handheld Pulse Oximeters with sensor accessories are non-invasive spot-check, oxygen saturation and pulse rate monitors. They operate on battery power using SOLARIS reusable Sp02 sensors for pediatric and adult patients.

Source page: https://510kreport.com/device/K073249
Methodology: https://510kreport.com/methodology