# K123797: NT1D Vital Signs Monitor

- Pathway: 510(k) (Traditional)
- Applicant: New Tech, Inc.
- Decided: Aug 27, 2013 after 260 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: 5 generations back to K001359 (2000). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032971: Tidal Wave SP Model 710/715                                       and 715, Respironics Novametrix, Inc. (2004) Summary page 2.
- K073249: Solaris NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories, Solaris Medical Technology, Inc. (2008) Summary page 2.
- K042601: Capnostat 5, Respironics Novametrix, Inc. (2004) Summary page 2.
- K053174: Loflo C5 CO2 Sensor, Respironics Novametrix, LLC (2006) Summary page 5.

## Indications for use
NTI D is a handheid vita! signs monitor that continuously monitors end tidal carbon dioxide (EtCO2), respiratory rate (RR), oxygen saturation (SpO2), and pulse rate. The unit is intended for monitoring only . The unit transfers history data to PC through aUSB adapter. It is for use in any environment where continuous, noninvasive monitoring of these parameters is desired, including hospital and hospital-type facilities. The monitor is intended for use on adult and pediatric patients.

Source page: https://510kreport.com/device/K123797
Methodology: https://510kreport.com/methodology