510(k) · Cleared
Recalled · Class II · 2023Rapidpoint 500 Blood Gas Analyer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · KHP Acid, Lactic, Enzymatic Method
Cleared on May 3, 2012 as substantially equivalent to K031560 (Bayer Healthcare, LLC, 2003) after a 184-day review. Its family tree reaches back 3 generations to 1995. It has been recalled 12 times.
- Decided
- May 3, 2012
- Review
- 184 days
- Class
- Class I
- Product code
- KHP
- Recalls
- 12
- Predicates
- 1
Its longest line of descent runs back 3 generations to K946206 (1995). 5 ancestors in all, the oldest K934907 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK946206 Ciba Corning 8-- Series CO-OximeterCiba Corning Diagnostics Corp. · 1995
- 2 generations backK020616 Bayer Rapidpoint 405 SystemBayer Diagnostics Corp. · 2002 · Recalled
- 1 generation backK031560 Bayer Rapidlab 1200 SystemBayer Healthcare, LLC · 2003 · Recalled
- This deviceK113216 Rapidpoint 500 Blood Gas AnalyerSiemens Healthcare Diagnostics · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K946206 | Ciba Corning 8-- Series CO-Oximeter | Ciba Corning Diagnostics Corp. | 1995 | — |
| −2 | K020616 | Bayer Rapidpoint 405 System | Bayer Diagnostics Corp. | 2002 | 4 |
| −1 | K031560 | Bayer Rapidlab 1200 System | Bayer Healthcare, LLC | 2003 | 14 |
| 0 (this device) | K113216 | Rapidpoint 500 Blood Gas Analyer | Siemens Healthcare Diagnostics | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 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 KHP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K031560 | Bayer Rapidlab 1200 SystemSummary page 1…Predicate Device Device Name Lactate on RAPlDLabo' 1200 Blood Gas System Common Name Lactate on blood gas system 510(k) Number K031 560 Manufacturer Siemens Healthcare Diagnostics Limited Device Description Lactate (Lac) is a new parameter offered on… | 2003 |
| * | — | RAPIDLab 1265 Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 26, 2023 | Class II | Z-0423-2024 | Under Investigation by firm | There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The erroneous sodium levels… |
| 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-2799-2016 | 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 5, 2016 | Class III | Z-2601-2016 | Under Investigation by firm | Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States |
| Aug 24, 2015 | Class II | Z-2813-2015 | Process control | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results |
| Aug 24, 2015 | Class II | Z-2816-2015 | Process control | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results |
| Aug 24, 2015 | Class II | Z-2814-2015 | Process control | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results |
| Aug 24, 2015 | Class II | Z-2815-2015 | Process control | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results |
| 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… |
| Dec 30, 2014 | Class II | Z-1253-2015 | Software design | Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl. |
| May 23, 2014 | Class II | Z-2079-2014 | Process design | RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-) |
| Sep 17, 2012 | Class II | Z-0104-2014 | 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 |
The 5 latest of 12 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 17 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- 3 of the 5 ancestors have a recall of any class.
How does its category compare?
All KHP devicesKHP Acid, Lactic, Enzymatic Method: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KHP
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · KHP
Too few KHP 510(k)s in any year since 2007 to give a median.
Recalls per year · KHP
3in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHP
9in 2025
MAUDE reports naming product code KHP, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 12 |
| 2014 | 0 | — | 1 | 19 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 3 | 41 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 13 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RAPIDPoint 500 system is intended for in vitro diagnostic use and is designed to provide the determination in whole blood for the following parameters: * Partial pressure of carbon dioxide * Partial pressure of oxygen * pH * Sodium * Potassium * Ionized calcium * Chloride * Glucose * Total hemoglobin and fractions: fO2Hb, fCOHb, fMetHb, fHHb * Neonatal bilirubin * Lactate This test system is intended for use in point of care or laboratory settings.…
Read the full statement (477 words)
The RAPIDPoint 500 system is intended for in vitro diagnostic use and is designed to provide the determination in whole blood for the following parameters:
* Partial pressure of carbon dioxide
* Partial pressure of oxygen
* pH
* Sodium
* Potassium
* Ionized calcium
* Chloride
* Glucose
* Total hemoglobin and fractions: fO2Hb, fCOHb, fMetHb, fHHb
* Neonatal bilirubin
* Lactate
This test system is intended for use in point of care or laboratory settings.
The following list includes the Indications for Use information for each analyte measured on the Rapidpoint 500 System:
Lactate. A lactic acid test system is a device intended to measure lactic acid in whole blood. 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).
Neonate Bilirubin. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).
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.
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/K113216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113216: Rapidpoint 500 Blood Gas Analyer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113216
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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