510(k) · Cleared
Recalled · Class II · 2025Bayer Rapidpoint 400 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Dec 19, 2000 after a 109-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled 7 times.
- Decided
- Dec 19, 2000
- Review
- 109 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 7
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK002738 Bayer Rapidpoint 400 SystemBayer Corp. · 2000
- Descendant · cites it directly · 1 of its ownK031560 Bayer Rapidlab 1200 SystemBayer Healthcare, LLC · 2003 · Recalled
- Descendant · cites it directly · 0 of its ownK151978 EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant…Edan Instruments, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK113216 Rapidpoint 500 Blood Gas AnalyerSiemens Healthcare Diagnostics · 2012 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K031560Bayer Rapidlab 1200 SystemBayer Healthcare, LLC · 2003 · cites it directly1descendant
- K151978EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN…Edan Instruments, Inc. · 2016 · cites it directly0descendants
- K113216Rapidpoint 500 Blood Gas AnalyerSiemens Healthcare Diagnostics · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002738 | Bayer Rapidpoint 400 System | Bayer Corp. | 2000 | — |
| +1 | K031560 | Bayer Rapidlab 1200 System | Bayer Healthcare, LLC | 2003 | 14 |
| +1 | K151978 | EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid… | Edan Instruments, Inc. | 2016 | — |
| +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 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CHL? 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 CHL device
- #1 K252207 ABL90 FLEX PLUS System, safeCLINITUBESscore 14.1 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2025 | Class II | Z-2230-2025 | Under Investigation by firm | 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, pH, Chloride, pCO2, Glucose and… |
| Sep 2, 2016 | Class III | Z-2912-2016 | Under Investigation by firm | 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 | Software design | 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 | 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 17, 2012 | Class II | Z-0102-2014 | Software Manufacturing/Software Deployment | 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 misidentification of the sample |
| Oct 30, 2009 | Not classified | Z-1019-2010 | Component design/selection | Software: Reference sensor failure may result in inaccurate pH reuslts |
| Oct 30, 2009 | Not classified | Z-1020-2010 | Component design/selection | Software: Reference sensor failure may result in inaccurate pH reuslts |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031560 (Bayer Healthcare, LLC, 2003) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CHL devicesCHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHL
267in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHL
13so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHL
210in 2025
MAUDE reports naming product code CHL, 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 | 1 | — | 6 | 16 |
| 2008 | 1 | — | 5 | 40 |
| 2009 | 0 | — | 6 | 74 |
| 2010 | 1 | — | 7 | 20 |
| 2011 | 4 | 108 | 1 | 50 |
| 2012 | 4 | 65 | 9 | 64 |
| 2013 | 5 | 152 | 1 | 62 |
| 2014 | 3 | 68 | 1 | 93 |
| 2015 | 4 | 155 | 3 | 55 |
| 2016 | 3 | 306 | 1 | 118 |
| 2017 | 1 | — | 1 | 206 |
| 2018 | 1 | — | 3 | 174 |
| 2019 | 0 | — | 0 | 141 |
| 2020 | 4 | 100 | 2 | 117 |
| 2021 | 2 | — | 0 | 147 |
| 2022 | 0 | — | 0 | 138 |
| 2023 | 5 | 267 | 4 | 177 |
| 2024 | 1 | — | 9 | 196 |
| 2025 | 1 | — | 0 | 210 |
| 2026 | 1 | — | 13 | — |
https://510kreport.com/device/K002738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002738: Bayer Rapidpoint 400 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002738
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026