# K980845: MS-900S, MS-900SPM & MS-900SFM

- Pathway: 510(k) (Traditional)
- Applicant: Mars Medical Products
- Decided: Dec 14, 1998 after 285 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Mars MS-900S, MS-900SFM & MS-900SPM Auto Inflation Wrist Blood Pressure Monitors are designed to provide signals from which systolic and diastolic pressures can be derived through the use of the oscillometric method. The devices also measure pulse rate.

Source page: https://510kreport.com/device/K980845
Methodology: https://510kreport.com/methodology