# K023745: Sechrist Air/Oxygen Mixer, Model 3500 CP-G

- Pathway: 510(k) (Traditional)
- Applicant: Sechrist Industries, Inc.
- Decided: Jan 17, 2003 after 71 days
- Product code: DTX (Gas Control Unit, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K802226 (1980). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K802226: Sechrist Series 3500 Air-Oxygen Mixer, Sechrist Industries, Inc. (1980) Summary page 1.
- K992503: Sechrist Air-Oxygen Mixer, 3500/3500HL Series, Sechrist Industries, Inc. (1999) Summary page 1.
- K841789: Sechrist Air-Oxygen Mixer & Ancillary, Shiley, Inc. (1984) Summary page 1.
- K863902: Modified Sarns Membrane Oxygenator, 3M Health Care, Sarns (1986) Summary page 1.
- K901253: (PBS) Portable Bypass System, Model 1000, Bio Medicus, Inc. (1990) Summary page 1.

## Most influential descendants
- K101046: Stockert S5 System and Gas Blender and Sorin C5 System (2010), 3 descendants of its own
- K181942: Quantum Ventilation Module (2018), 2 descendants of its own
- K202733: Quantum Ventilation Module (2020), 1 descendant of its own
- K210669: Quantum Mini Ventilation Module (2021), 0 descendants of its own

## Indications for use
The intended use of the Sechrist Model 3500CP-G Aidoxygen Mixer is to enable qualified personnel to mix medical grade air and medical grade oxygen at operator selected ratios, for delivery to patients through various types of respiratory care and heart bypass oxygenation equipment.

Source page: https://510kreport.com/device/K023745
Methodology: https://510kreport.com/methodology