510(k) · Cleared
Recalled · Class II · 2016Rapidpoint 405 Neonatal Bilirubin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · MQM Bilirubin (Total And Unbound) In The Neonate Test System
Cleared on Aug 15, 2011 as substantially equivalent to K073537 (Siemens Medical Solutions Diagnostics, 2008) after a 196-day review. Its family tree reaches back 7 generations to 1986. It has been recalled 5 times.
- Decided
- Aug 15, 2011
- Review
- 196 days
- Class
- Class I
- Product code
- MQM
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 7 generations to K861087 (1986). 22 ancestors in all, the oldest K790608 (1979). No later device cites it as a predicate yet.
- Root · 7 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 6 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
- 5 generations backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
- 4 generations backK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- 3 generations backK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
- 2 generations backK043218 ABL800 Flex with Flexq Module, Model ABL8XXRadiometer Medical Aps · 2005 · Recalled
- 1 generation backK073537 Neonatal Bilirubin on Rapidlab Models 1245 and 1265Siemens Medical Solutions Diagnostics · 2008 · Recalled
- This deviceK110277 Rapidpoint 405 Neonatal BilirubinSiemens Healthcare Diagnostics · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| −6 | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | 1 |
| −5 | K972673 | Avl 9181 Electrolyte Analyzer | Avl Scientific Corp. | 1997 | 7 |
| −4 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| −3 | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | 22 |
| −2 | K043218 | ABL800 Flex with Flexq Module, Model ABL8XX | Radiometer Medical Aps | 2005 | 3 |
| −1 | K073537 | Neonatal Bilirubin on Rapidlab Models 1245 and 1265 | Siemens Medical Solutions Diagnostics | 2008 | 7 |
| 0 (this device) | K110277 | Rapidpoint 405 Neonatal Bilirubin | Siemens Healthcare Diagnostics | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 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 MQM? 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? (3)
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 |
|---|---|---|---|
| * | K073537 | Neonatal Bilirubin on Rapidlab Models 1245 and 1265Summary page 1…al Bilirubin on RAPlDLab' 1200 Blood Gas System Common Name Neonate bilirubin on blood gas system 510(k) Number K073537 Manufacturer Siemens H-ealthcare Diagnostics Limited Device Description Neonatal Bilirubin (nBili) is a new para… | 2008 |
| * | — | RAPIDLab 1245 Named without a submission number | |
| * | — | 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 2, 2016 | Class III | Z-2913-2016 | 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-2798-2016 | 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… |
| Dec 30, 2014 | Class II | Z-1252-2015 | 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. |
| Sep 17, 2012 | Class II | Z-0103-2014 | 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 |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 13 of the 22 ancestors have a recall of any class.
How does its category compare?
All MQM devicesMQM Bilirubin (Total And Unbound) In The Neonate Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MQM
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MQM
Too few MQM 510(k)s in any year since 2007 to give a median.
Recalls per year · MQM
No recall names MQM since 2007.
Adverse event reports per year · MQM
2in 2025
MAUDE reports naming product code MQM, 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 | 5 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 14 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RAPIDPoint 405 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, fNHb * Neonatal bilirubin This test system is intended for use in point of care or laboratory settings. PCO2, PO2…
Read the full statement (414 words)
The RAPIDPoint 405 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, fNHb
* Neonatal bilirubin
This test system is intended for use in point of care or laboratory settings.
PCO2, PO2, pH. Measurements of blood gases (pCO2, pO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
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).
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/K110277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110277: Rapidpoint 405 Neonatal Bilirubin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110277
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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