# K090147: Blood Monitoring Unit, Model Bmu 40

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Apr 22, 2009 after 91 days
- Product code: DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K931968 (1993). 9 ancestors in all.
3 later devices descend from it; 1 cites it directly.
2 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972962: 3M Cdi Blood Parameter Monitoring System 500, 3M Company (1997) Summary page 1.
- K072131: M3 Monitor, Spectrum Medical, Ltd. (2007) Summary page 1.

## Most influential descendants
- K102726: Cardiohelp System (2011), 2 descendants of its own
- K133598: Cardiohelp System (2014), 0 descendants of its own
- K133265: Quadrox-IR Adult and Small Adult (2013), 0 descendants of its own

## Recalls of this device
- Sep 30, 2020 · Class II · Z-0443-2021: The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, third edition). The BMU 40 units affected by this recall were designed with a short creepage distance of

## Indications for use
The intended purpose of the MAQUET Blood Monitoring Unit BMU 40 is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pO2), temperature (Ta and Tv), oxygen saturation (SO2), hemoglobin (Hb) and hematocrit (Hct). Oxygen consumption (VO2) can also be calculated. Blood flow (QBlood) can be entered manually or values can be received from a connected heart-lung machine. The duration of application of the disposable products (arterial BMU Sensor and venous BMU Cell) is limited to six hours. The BMU 40 is designed for continuous operation.

Source page: https://510kreport.com/device/K090147
Methodology: https://510kreport.com/methodology