# K012553: Gsibp Blood Pressure Cuff

- Pathway: 510(k) (Abbreviated)
- Applicant: Globalshop, Inc.
- Decided: Aug 17, 2001 after 9 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
Longest line of descent: 1 generation back to K962655 (1997). 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)
- K962655: Aneroid and Mercurial Sphygmomanometers, American Diagnostic Corp. (1997) Summary page 1.

## Indications for use
Personnel properly trained in the use of blood pressure measurement devices use the GSIBP blood pressure cuff in conjunction with non-invasive blood pressure measurement systems. The device is non-sterile and is intended as a reusable multi-patient device. It is available in child through large adult sizes.

Source page: https://510kreport.com/device/K012553
Methodology: https://510kreport.com/methodology