# K012444: Abn Aneroid Sphygmomanometer

- Pathway: 510(k) (Traditional)
- Applicant: Pt. Sugih Instrumendo Abadi
- Decided: Aug 16, 2001 after 15 days
- Product code: DXQ (Blood Pressure Cuff)
- Device class: 2
- Regulation: 21 CFR 870.1120
- 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
An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure the systolic and diastolic blood pressures by means of a manually inflatable cuff and a manometer analog gauge. These devices will be used by physicians, nurses, paramedics and retail consumers.

Source page: https://510kreport.com/device/K012444
Methodology: https://510kreport.com/methodology