510(k) · Cleared
Recalled · Class II · 2018Bayer Rapidpoint 405 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Diagnostics Corp. · GKR System, Hemoglobin, Automated
Cleared on Jul 17, 2002 as substantially equivalent to K946206 (Ciba Corning Diagnostics Corp., 1995) after a 142-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Jul 17, 2002
- Review
- 142 days
- Class
- Class II
- Product code
- GKR
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946206 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK946206 Ciba Corning 8-- Series CO-OximeterCiba Corning Diagnostics Corp. · 1995
- This deviceK020616 Bayer Rapidpoint 405 SystemBayer Diagnostics Corp. · 2002
- Descendant · cites it directly · 1 of its ownK031560 Bayer Rapidlab 1200 SystemBayer Healthcare, LLC · 2003 · Recalled
- Descendant · 2 generations on · 0 of its ownK113216 Rapidpoint 500 Blood Gas AnalyerSiemens Healthcare Diagnostics · 2012 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946206 | Ciba Corning 8-- Series CO-Oximeter | Ciba Corning Diagnostics Corp. | 1995 | — |
| 0 (this device) | K020616 | Bayer Rapidpoint 405 System | Bayer Diagnostics Corp. | 2002 | — |
| +1 | K031560 | Bayer Rapidlab 1200 System | Bayer Healthcare, LLC | 2003 | 14 |
| +2 | K113216 | Rapidpoint 500 Blood Gas Analyer | Siemens Healthcare Diagnostics | 2012 | 12 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GKR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GKR device
- #1 K201217 HemoCue Hb 301 Systemscore 0.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K946206 | Ciba Corning 8-- Series CO-OximeterSummary page 1…ate Device Information I Name Rapidlab 800 Series eo-oximeter Manufacturer Bayer Corporation 51O(k) Number K946206 4. Device Description The Rapidpoint 405 system Co-ox measurement cartridge measures the light from the whole… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031560 | Bayer Rapidlab 1200 System | 2003 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 16, 2018 | Class II | Z-2927-2018 | Device Design | 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 cause lower than expected values for… |
| Jul 16, 2018 | Class II | Z-2928-2018 | Device Design | 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 cause lower than expected values for… |
| Jul 28, 2015 | Class II | Z-2479-2015 | Software design | 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 include either: duplicate data… |
| Sep 26, 2003 | Not classified | Z-0066-04 | Other | Potential for bias shift in pO2 values due to air bubble in sample path |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GKR devicesGKR System, Hemoglobin, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKR
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · GKR
Too few GKR 510(k)s in any year since 2007 to give a median.
Recalls per year · GKR
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKR
1in 2024
MAUDE reports naming product code GKR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 16 |
| 2010 | 0 | — | 1 | 9 |
| 2011 | 1 | — | 1 | 12 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 2 | — | 1 | 43 |
| 2014 | 0 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 19 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 9 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020616: Bayer Rapidpoint 405 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020616
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026