# K002738: Bayer Rapidpoint 400 System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Dec 19, 2000 after 109 days
- Product code: CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)
- Device class: 2
- Regulation: 21 CFR 862.1120
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K031560: Bayer Rapidlab 1200 System (2003), 1 descendant of its own
- K151978: EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control (2016), 0 descendants of its own
- K113216: Rapidpoint 500 Blood Gas Analyer (2012), 0 descendants of its own

## Recalls of this device
- Jun 26, 2025 · Class II · Z-2230-2025: Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, 
- Sep 2, 2016 · Class III · Z-2912-2016: Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge
- Aug 11, 2016 · Class II · Z-2797-2016: There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
- Jul 28, 2015 · Class II · Z-2479-2015: When both ports (Serial and Ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port causing the data management system to 
- Sep 17, 2012 · Class II · Z-0102-2014: RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misiden
- Oct 30, 2009 · Not classified · Z-1019-2010: Software: Reference sensor failure may result in inaccurate pH reuslts
- Oct 30, 2009 · Not classified · Z-1020-2010: Software: Reference sensor failure may result in inaccurate pH reuslts

Source page: https://510kreport.com/device/K002738
Methodology: https://510kreport.com/methodology