# K983855: Fuzzy Type Digital Blood Pressure Monitor, Model #'S HD-1000S & HD-2000F

- Pathway: 510(k) (Traditional)
- Applicant: Jawon Medical Co., Ltd.
- Decided: Nov 17, 1998 after 15 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: 1 generation back to K895429 (1989). 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)
- K895429: A&D Automatic Digital Blood Pressure Meter 2650, A&D Engineering, Inc. (1989) Summary page 1.

## Indications for use
Noninvasive measurement of systolic and diastolic blood pressure and heart rate in adult patients, i.e., age 15 and above, in a home care environment.

Source page: https://510kreport.com/device/K983855
Methodology: https://510kreport.com/methodology