# K041789: Noninvasive Blood Pressure Monitor, Models MD-880B and MD-900T

- Pathway: 510(k) (Traditional)
- Applicant: Meditec Co., Ltd.
- Decided: Jul 15, 2004 after 13 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
Longest line of descent: 2 generations back to K952826 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001671: Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model Hem-630, Omron Healthcare, Inc. (2000) Summary page 1.
- K992328: Fuzzy Automatic Blood Pressure Monitor Models MD-750, MD-770, MD-800, Meditec Co., Ltd. (1999) Summary page 1.

## Indications for use
Measuring Systolic and Diastolic blood pressure and pulse rates in adult patients with arm circumferences between 5{ -74 inches using the oscillometric method

Source page: https://510kreport.com/device/K041789
Methodology: https://510kreport.com/methodology