510(k) · Cleared
Recalled · Class II · 2018Bayer Rapidlab 1200 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, LLC · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Dec 17, 2003 as substantially equivalent to K934907 (Ciba Corning Diagnostics Corp., 1994) and 3 other predicates after a 212-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it. It has been recalled 14 times.
- Decided
- Dec 17, 2003
- Review
- 212 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 14
- Predicates
- 4
Its longest line of descent runs back 2 generations to K946206 (1995). 4 ancestors in all, the oldest K934907 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK946206 Ciba Corning 8-- Series CO-OximeterCiba Corning Diagnostics Corp. · 1995
- 1 generation backK020616 Bayer Rapidpoint 405 SystemBayer Diagnostics Corp. · 2002 · Recalled
- This deviceK031560 Bayer Rapidlab 1200 SystemBayer Healthcare, LLC · 2003
- Descendant · cites it directly · 0 of its ownK113216 Rapidpoint 500 Blood Gas AnalyerSiemens Healthcare Diagnostics · 2012 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K113216Rapidpoint 500 Blood Gas AnalyerSiemens Healthcare Diagnostics · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K946206 | Ciba Corning 8-- Series CO-Oximeter | Ciba Corning Diagnostics Corp. | 1995 | — |
| −1 | K020616 | Bayer Rapidpoint 405 System | Bayer Diagnostics Corp. | 2002 | 4 |
| 0 (this device) | K031560 | Bayer Rapidlab 1200 System | Bayer Healthcare, LLC | 2003 | — |
| +1 | K113216 | Rapidpoint 500 Blood Gas Analyer | Siemens Healthcare Diagnostics | 2012 | 12 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (4)
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 |
|---|---|---|---|
| * | K934907 | 860 Measurment SystemSummary page 1…Rapidlab 800 Series Rapidpoint 400 Series Manufacturer: Bayer Healthcare, LLC Bayer Healthcare, LLC 510(k) Number: # K934907 # K002738 # K946206 # K020616… | 1994 |
| * | K946206 | Ciba Corning 8-- Series CO-OximeterSummary page 1…Bayer Healthcare, LLC Bayer Healthcare, LLC 510(k) Number: # K934907 # K002738 # K946206 # K020616 Appendix A Summary of Safet… | 1995 |
| * | K002738 | Bayer Rapidpoint 400 SystemSummary page 1…Rapidpoint 400 Series Manufacturer: Bayer Healthcare, LLC Bayer Healthcare, LLC 510(k) Number: # K934907 # K002738 # K946206 # K020616 Appe… | 2000 |
| * | K020616 | Bayer Rapidpoint 405 SystemSummary page 1…LLC Bayer Healthcare, LLC 510(k) Number: # K934907 # K002738 # K946206 # K020616 Appendix A Summary of Safety and Effectiveness 4. Device… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113216 | Rapidpoint 500 Blood Gas Analyer | 2012 | 0 |
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-2930-2018 | 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-2929-2018 | 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… |
| Apr 10, 2017 | Class II | Z-2040-2017 | Software design | Potential Patient Demographic Error with Blank Patient ID Field |
| Aug 11, 2016 | Class II | Z-2801-2016 | 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 |
| Aug 11, 2016 | Class II | Z-2800-2016 | 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 |
| May 6, 2015 | Class II | Z-1961-2015 | Software design | D50 and D51 Diagnostic error codes are not functional. |
| Sep 17, 2012 | Class II | Z-0106-2014 | 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 |
| Sep 17, 2012 | Class II | Z-0105-2014 | 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 |
| Apr 4, 2006 | Not classified | Z-1464-06 | Software design | Invalid CO-oximeter values; Bayer HealthCare determined that under very specific conditions, the RapidLab 1245 or RapidLab 1265 systems may report invalid CO-oximeter values to an LIS, Rapidlink, or Rapidcomm™ data management system. |
| Apr 4, 2006 | Not classified | Z-1465-06 | Software design | Invalid CO-oximeter values; Bayer HealthCare determined that under very specific conditions, the RapidLab 1245 or RapidLab 1265 systems may report invalid CO-oximeter values to an LIS, Rapidlink, or Rapidcomm™ data management system. |
| Jan 20, 2006 | Not classified | Z-0682-06 | Other | When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions… |
| Jan 20, 2006 | Not classified | Z-0683-06 | Other | When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions… |
| Jan 20, 2006 | Not classified | Z-0684-06 | Other | When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions… |
| Jan 20, 2006 | Not classified | Z-0685-06 | Other | When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions… |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K113216 (Siemens Healthcare Diagnostics, 2012) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K934907.
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 | — |
What is it indicated for?
The Rapidlab 1200 system series is intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of samples of whole blood for the following parameters: * partial pressure of carbon dioxide * partial pressure of oxygen * pH * sodium * potassium * ionized calcium * chloride * glucose * lactate * CO-oximetry parameters (tHb, FO2Hb, FCOHb, FMetHb, FHHb) The following list includes the indication for use information for each…
Read the full statement (404 words)
The Rapidlab 1200 system series is intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of samples of whole blood for the following parameters:
* partial pressure of carbon dioxide
* partial pressure of oxygen
* pH
* sodium
* potassium
* ionized calcium
* chloride
* glucose
* lactate
* CO-oximetry parameters (tHb, FO2Hb, FCOHb, FMetHb, FHHb)
The following list includes the indication for use information for each analyte measured on the Rapidlab 1200 System Series:
pCO 2, P0 2,pH. Measurements of blood gases (PCO2, P02) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Sodium. Sodium measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
Potassium. Potassium measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Chloride. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Ionized calcium. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Glucose. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Lactate. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
Total hemoglobin. Total hemoglobin measurements are used to determine the hemoglobin content of human blood.
Oxyhemoglobin. Oxyhemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.
Carboxyhemoglobin. Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin (the compound formed when hemoglobin is exposed to carbon monoxide) content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
Sulfhemoglobin. Sulfhemoglobin measurements are used to determine the sulfhemoglobin (a compound of sulfur and hemoglobin) content of human blood as an aid in the diagnosis of sulfhemoglobinemia (presence of sulfhemoglobin in the blood due to drug administration or exposure to a poison).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031560: Bayer Rapidlab 1200 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031560
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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