510(k) · Cleared
Recalled · Class I · 2018Draeger Jaundice Meter JM-105
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Systems, Inc. · MQM Bilirubin (Total And Unbound) In The Neonate Test System
Cleared on Nov 13, 2014 as substantially equivalent to K042522 (Draeger Medical Infant Care, Inc., 2005) after a 392-day review. Its family tree reaches back 4 generations to 1981. 2 of the 5 devices in its family, counting itself, have a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Nov 13, 2014
- Review
- 392 days
- Class
- Class I
- Product code
- MQM
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 4 generations to P810007 (1981). No later device cites it as a predicate yet. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backP810007 Jaundice Meter 101Narco Scientific · 1981
- 3 generations backK972309 JM-102 Jaundice MeterAir-Shields, Inc. · 1998
- 2 generations backK021622 Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103Hill-Rom Air-Shields · 2003
- 1 generation backK042522 Jaundice Meter, Model JM 103Draeger Medical Infant Care, Inc. · 2005 · Recalled (Class I)
- This deviceK133175 Draeger Jaundice Meter JM-105Draeger Medical Systems, Inc. · 2014
Class I recalls in this family
- K042522 Jaundice Meter, Model JM 103direct predicate · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P810007 | Jaundice Meter 101 | Narco Scientific | 1981 | — |
| −3 | K972309 | JM-102 Jaundice Meter | Air-Shields, Inc. | 1998 | — |
| −2 | K021622 | Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103 | Hill-Rom Air-Shields | 2003 | — |
| −1 | K042522 | Jaundice Meter, Model JM 103 | Draeger Medical Infant Care, Inc. | 2005 | Class I |
| 0 (this device) | K133175 | Draeger Jaundice Meter JM-105 | Draeger Medical Systems, Inc. | 2014 | — |
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 |
|---|---|---|---|
| * | K042522 | Jaundice Meter, Model JM 103Summary page 4…Product Code: MQM Class: I, reserved Predicate Devices: 510(k) Number Device Name K042522 Draeger JM-103 Jaundice Meter Intended Use/Indications for Use The Jaundice Meter (JM-105) i… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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-2047-2018 | Device Design | Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" 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.
- K042522Jaundice Meter, Model JM 103Draeger Medical Infant Care, Inc. · 2005 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 9.4 years on median.
- 1 of the 4 ancestors has a recall of any class; 1 has a Class I recall.
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. 2014, 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 Jaundice Meter (JM-105) 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-105) 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-105 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 105 is a prescription medical device
The JM 105 is not intended for home use.
The JM 105 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/K133175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133175: Draeger Jaundice Meter JM-105.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133175
Report an extraction error
Are you the manufacturer?
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