# K020616: Bayer Rapidpoint 405 System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Diagnostics Corp.
- Decided: Jul 17, 2002 after 142 days
- Product code: GKR (System, Hemoglobin, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5620
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K946206 (1995). 1 ancestor in all.
2 later devices descend from it; 1 cites 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)
- K946206: Ciba Corning 8-- Series CO-Oximeter, Ciba Corning Diagnostics Corp. (1995) Summary page 1.

## Most influential descendants
- K031560: Bayer Rapidlab 1200 System (2003), 1 descendant of its own
- K113216: Rapidpoint 500 Blood Gas Analyer (2012), 0 descendants of its own

## Recalls of this device
- Jul 16, 2018 · Class II · Z-2927-2018: Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may
- Jul 16, 2018 · Class II · Z-2928-2018: Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may
- 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 26, 2003 · Not classified · Z-0066-04: Potential for bias shift in pO2 values due to air bubble in sample path

## Indications for use
The Rapidpoint 405 System Co-ox measurement cartridge measures total hemoglobin and hemoglobin fractions and derivatives in arterial, venous and capillary whole blood samples. Hemoglobin fractions and derivatives are listed below: Fractions: tHb, F02Hb, FCOHb, FMetHb, FHHb

Source page: https://510kreport.com/device/K020616
Methodology: https://510kreport.com/methodology