# K854357: Gem-6, with Components

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Electro-Tech, Inc.
- Decided: Jan 8, 1986 after 71 days
- Product code: DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
2 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K972962: 3M Cdi Blood Parameter Monitoring System 500 (1997), 10 descendants of its own
- K110957: M4 Monitor (2011), 4 descendants of its own
- K173591: Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas (2018), 3 descendants of its own
- K090147: Blood Monitoring Unit, Model Bmu 40 (2009), 3 descendants of its own
- K181942: Quantum Ventilation Module (2018), 2 descendants of its own

Source page: https://510kreport.com/device/K854357
Methodology: https://510kreport.com/methodology