510(k) · Cleared
Recalled · Class II · 2016Neonatal Bilirubin on Rapidlab Models 1245 and 1265
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions Diagnostics · MQM Bilirubin (Total And Unbound) In The Neonate Test System
Cleared on Jun 27, 2008 as substantially equivalent to K043218 (Radiometer Medical Aps, 2005) and 1 other predicate after a 193-day review. Its family tree reaches back 6 generations to 1986. 1 later device descends from it. It has been recalled 7 times.
- Decided
- Jun 27, 2008
- Review
- 193 days
- Class
- Class I
- Product code
- MQM
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 6 generations to K861087 (1986). 21 ancestors in all, the oldest K790608 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 5 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
- 4 generations backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
- 3 generations backK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- 2 generations backK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
- 1 generation backK043218 ABL800 Flex with Flexq Module, Model ABL8XXRadiometer Medical Aps · 2005 · Recalled
- This deviceK073537 Neonatal Bilirubin on Rapidlab Models 1245 and 1265Siemens Medical Solutions Diagnostics · 2008
- Descendant · cites it directly · 0 of its ownK110277 Rapidpoint 405 Neonatal BilirubinSiemens Healthcare Diagnostics · 2011 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K110277Rapidpoint 405 Neonatal BilirubinSiemens Healthcare Diagnostics · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| −5 | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | 1 |
| −4 | K972673 | Avl 9181 Electrolyte Analyzer | Avl Scientific Corp. | 1997 | 7 |
| −3 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| −2 | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | 22 |
| −1 | K043218 | ABL800 Flex with Flexq Module, Model ABL8XX | Radiometer Medical Aps | 2005 | 3 |
| 0 (this device) | K073537 | Neonatal Bilirubin on Rapidlab Models 1245 and 1265 | Siemens Medical Solutions Diagnostics | 2008 | — |
| +1 | K110277 | Rapidpoint 405 Neonatal Bilirubin | Siemens Healthcare Diagnostics | 2011 | 5 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (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 |
|---|---|---|---|
| * | K043218 | ABL800 Flex with Flexq Module, Model ABL8XXSummary page 1…ABL800 FLEX ABL735 Common name Blood gas analyzer Blood gas analyzer 510(k) Number K043218 K991417 Manufacturer Radiometer Medical ApS Radiometer America Device D… | 2005 |
| * | K991417 | Abl 735 AnalyzerSummary page 1…ABL735 Common name Blood gas analyzer Blood gas analyzer 510(k) Number K043218 K991417 Manufacturer Radiometer Medical ApS Radiometer America Device Description Neonatal Bilirubin (nBili… | 1999 |
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 |
|---|---|---|---|
| K110277 | Rapidpoint 405 Neonatal Bilirubin | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 11, 2016 | Class II | Z-2802-2016 | 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-2803-2016 | 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-1962-2015 | Software design | D50 and D51 diagnostic error codes are not functional. |
| Dec 30, 2014 | Class II | Z-1254-2015 | 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. |
| Dec 30, 2014 | Class II | Z-1255-2015 | 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-0107-2014 | 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-0108-2014 | 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 7 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 22 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 12 of the 21 ancestors have a recall of any class.
- Of its descendants, K110277 (Siemens Healthcare Diagnostics, 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K043218.
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. 2008, 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 neonatal bilirubin test intended use on the Rapidlab 1245 and Rapidlab 1265 analyzers is an in vitro diagnostic test for the determination of total neonatal bilirubin (nBili) concentration in the whole blood of newborn infants. Measurement of nBili aids in assessing the risk of kernicterus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073537 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073537: Neonatal Bilirubin on Rapidlab Models 1245 and 1265.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073537
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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