# K994372: MODEL 120

- Pathway: 510(k) (Traditional)
- Applicant: Palco Labs, Inc.
- Decided: Apr 28, 2000 after 123 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071642: Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse Oximeter (2008), 0 descendants of its own
- K061896: Mediaid Disposable Non-Adhesive Sensors, Model CST050-2101N; Reusable Finger Clip SP02 Sensors, Model CST060-2101N (2007), 0 descendants of its own

## Indications for use
The Model 120 is intended to be used in the hospital, doctor’s office, emergency medical facilities, or home care environments to measure %SpO2 and heart rate. The Model 120 is intended for use in short-term monitoring on adults and children. The Model 120 will be operated by a physician, nurse, or medical technician.

Source page: https://510kreport.com/device/K994372
Methodology: https://510kreport.com/methodology