# K081572: Smartsigns Minpulse

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Healthcare, Ltd.
- Decided: Oct 1, 2008 after 119 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 K945754 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945754: NEWOX2, Bci Intl., Inc. (1995) Summary page 1.

## Indications for use
The Smartsigns MP1 and MP1R handheld pulse oximeter is intended for non-invasive continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate. It is intended for use by healthcare professionals for monitoring adult and pediatric patients in hospitals and hospital-type facilities. The specific medical indications for the use of this device is: · This device is a prescription device · This device is re-useable and is intended for spot or continuous measurement · This device is intended to display oxygen saturation, heart rate and pulse strength or pulsatile signal. · This device is intended to indicate an alarm if the measured saturation or heart rate are outside user-set alarm limits.

Source page: https://510kreport.com/device/K081572
Methodology: https://510kreport.com/methodology