# K972301: Big Ben Square, Big Ben Round

- Pathway: 510(k) (Traditional)
- Applicant: Rudolf Riester GmbH & Co. KG
- Decided: Sep 17, 1997 after 90 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K101892: Heine Gamma G7; Heine Gamma G5, Heine Gamma GP, Heine Gamma GST, Heine Gamma XXL LF Model M-000.09.23X, M-000.09.24X, M- (2010), 0 descendants of its own

## Indications for use
Big Ben Square and Big Ben Round models are sphygmomanomte: and are intended to measure the blood pressure.

Source page: https://510kreport.com/device/K972301
Methodology: https://510kreport.com/methodology