# 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-

- Pathway: 510(k) (Traditional)
- Applicant: Heine Optotechnik GmbH & Co. KG
- Decided: Aug 27, 2010 after 51 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 K972301 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972379: Precisa N, Rudolf Riester GmbH & Co. KG (1997) Summary page 2.
- K002954: RI-San/RI-Sana Blood Pressure Manometers, Rudolf Riester GmbH & Co. KG (2000) Summary page 2.
- K972301: Big Ben Square, Big Ben Round, Rudolf Riester GmbH & Co. KG (1997) Summary page 2.
- K972378: Sanaphon N, Rudolf Riester GmbH & Co. KG (1997) Summary page 2.

## Indications for use
HEINE GAMMA aneroid sphygmomanometers are exclusively designed for measuring blood pressure at the upper arm or thigh on healthy skin.

Source page: https://510kreport.com/device/K101892
Methodology: https://510kreport.com/methodology