510(k) · Cleared
Recalled · Class I · 2018Jaundice Meter, Model JM 103
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Infant Care, Inc. · MQM Bilirubin (Total And Unbound) In The Neonate Test System
Cleared on Jul 6, 2005 as substantially equivalent to K021622 (Hill-Rom Air-Shields, 2003) after a 293-day review. Its family tree reaches back 3 generations to 1981. 2 of the 5 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once, including a Class I recall.
- Decided
- Jul 6, 2005
- Review
- 293 days
- Class
- Class I
- Product code
- MQM
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 3 generations to P810007 (1981). 1 later device descends from it, 1 citing it directly. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backP810007 Jaundice Meter 101Narco Scientific · 1981
- 2 generations backK972309 JM-102 Jaundice MeterAir-Shields, Inc. · 1998
- 1 generation backK021622 Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103Hill-Rom Air-Shields · 2003
- This deviceK042522 Jaundice Meter, Model JM 103Draeger Medical Infant Care, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK133175 Draeger Jaundice Meter JM-105Draeger Medical Systems, Inc. · 2014 · Recalled (Class I)
Class I recalls in this family
- K133175 Draeger Jaundice Meter JM-105cites it directly · 2014
Most influential descendants
Showing 1 of 1 · See all- K133175Draeger Jaundice Meter JM-105Draeger Medical Systems, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P810007 | Jaundice Meter 101 | Narco Scientific | 1981 | — |
| −2 | K972309 | JM-102 Jaundice Meter | Air-Shields, Inc. | 1998 | — |
| −1 | K021622 | Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103 | Hill-Rom Air-Shields | 2003 | — |
| 0 (this device) | K042522 | Jaundice Meter, Model JM 103 | Draeger Medical Infant Care, Inc. | 2005 | — |
| +1 | K133175 | Draeger Jaundice Meter JM-105 | Draeger Medical Systems, Inc. | 2014 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 1 |
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.
2 devices in this family have a Class I recall. 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? (1)
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 |
|---|---|---|---|
| * | K021622 | Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103Summary page 1…Test Systems 21 CFR 862.113 Bilirubin in the Neonatal Test System, MVQM, Class I Performance Standards: None applicable Predicate Device: K021622 JM 103 Jaundice Meter Device Description The JM-1 03 Jaundice Meter is designed to provide a transcutaneous measurement… | 2003 |
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 |
|---|---|---|---|
| K133175 | Draeger Jaundice Meter JM-105 Class I | 2014 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 15, 2018 | Class I | Z-2046-2018 | Device Design | Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K133175Draeger Jaundice Meter JM-105Draeger Medical Systems, Inc. · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K133175 (Draeger Medical Systems, Inc., 2014) has gone furthest, with 0 descendants of its own.
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.
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 Jaundice Meter (JM-103) is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants. The unit provides a visual digital measurement that has been shown to correlate with serum bilirubin in newborn infants. The device is intended for use in hospitals, clinics or doctor's offices under a physicians supervision / direction to assist clinicians in monitoring of newborn infants. The device is not…
Read the full statement (163 words)
The Jaundice Meter (JM-103) is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants. The unit provides a visual digital measurement that has been shown to correlate with serum bilirubin in newborn infants.
The device is intended for use in hospitals, clinics or doctor's offices under a physicians supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements.
Newborn infants whose JM-103 Jaundice Meter test results are indicative of hyperbilirubinemia should be evaluated by their physician(s) for appropriate patient management. Specific neonatal patient Bilirubin levels should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations.
The JM 103 is a prescription Medical Device
The JM 103 is not intended for home use.
The JM 103 may only be used at the sternum measurement site for Physician's office applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042522 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042522: Jaundice Meter, Model JM 103.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042522
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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