# K990638: Aneroid Sphygmomanometer

- Pathway: 510(k) (Abbreviated)
- Applicant: Genmed, Inc.
- Decided: Oct 7, 1999 after 223 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K123130: Answatch Wrist Monitor Model TS-0411 (2013), 2 descendants of its own
- K213699: CareTaker Monitor App (2022), 0 descendants of its own
- K201914: HRVWatch-Mini Wrist Monitor (2021), 0 descendants of its own

## Indications for use
These devices are intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotokoff sounds. This device is indicated for use by medical personnel or for home use.

Source page: https://510kreport.com/device/K990638
Methodology: https://510kreport.com/methodology