# K071642: Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Mediaid, Inc.
- Decided: May 2, 2008 after 319 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 K910772 (1991). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943842: Pulse Oximeter Model 305, Palco Laboratories, Inc. (1995) Summary page 2.
- K920066: Palco Labs Model 340 Pulse Oximeter, Palco Laboratories, Inc. (1993) Summary page 2.
- K994372: MODEL 120, Palco Labs, Inc. (2000) Summary page 2.
- K040490: Welch Allyn Spot Ultra Vital Signs Device, Welch Allyn, Inc. (2004) Summary page 2.
- K053209: Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement System, Suntech Medical, Inc. (2006) Summary page 2.

## Indications for use
The Model 960 Series is a desktop monitor intended for use as a continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, non invasive blood pressure and temperature. The intended patient population comprises adult, and pediatric weighing more than 5Kg. The intended environment of use is hospital environment. Hospital use typically covers areas such as general care floors, operating rooms, special procedure areas, intensive and critical care areas within the hospital plus hospital-type facilities such as surgical centers, sub-acute centers, special nursing facilities and sleep labs. The Model 900 is an Pulse Oximeter only. WARNING: The Model 900 and 960 Series is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.

Source page: https://510kreport.com/device/K071642
Methodology: https://510kreport.com/methodology