510(k) · Cleared
ClearedHill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill-Rom Air-Shields · MQM Bilirubin (Total And Unbound) In The Neonate Test System
Cleared on Apr 1, 2003 as substantially equivalent to K972309 (Air-Shields, Inc., 1998) after a 320-day review. Its family tree reaches back 2 generations to 1981. 2 of the 5 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Apr 1, 2003
- Review
- 320 days
- Class
- Class I
- Product code
- MQM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P810007 (1981). 2 later devices descend from it, 1 citing it directly. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backP810007 Jaundice Meter 101Narco Scientific · 1981
- 1 generation backK972309 JM-102 Jaundice MeterAir-Shields, Inc. · 1998
- This deviceK021622 Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103Hill-Rom Air-Shields · 2003
- Descendant · cites it directly · 1 of its ownK042522 Jaundice Meter, Model JM 103Draeger Medical Infant Care, Inc. · 2005 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK133175 Draeger Jaundice Meter JM-105Draeger Medical Systems, Inc. · 2014 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P810007 | Jaundice Meter 101 | Narco Scientific | 1981 | — |
| −1 | K972309 | JM-102 Jaundice Meter | Air-Shields, Inc. | 1998 | — |
| 0 (this device) | 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 |
| +2 | 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 |
|---|---|---|
| 2005 | 1 | 1 |
| 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 |
|---|---|---|---|
| * | K972309 | JM-102 Jaundice MeterSummary page 1…CFR 862.1113 Bilirubin in the Neonatal Test System, MQM, Class I Performance Standards : None applicable Predicate Device: JM 102 Jaundice Meter K972309 Device Description: The JM 103 Jaundice Meter is designed to provide a non-invasive measurement of the yellowness of subc… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042522 | Jaundice Meter, Model JM 103 Class I | 2005 | 1 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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 · Cites it directly · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
- K133175Draeger Jaundice Meter JM-105Draeger Medical Systems, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 16.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K042522 (Draeger Medical Infant Care, Inc., 2005) has gone furthest, with 1 descendant 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 and displays a measured value which has been shown to correlate with serum bilirubin. The device is for use in the hospital to assist clinicians in monitoring the status of newborn infants for the development of hyperbilirubinemia. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It…
Read the full statement (127 words)
The Jaundice Meter (JM-103) is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants and displays a measured value which has been shown to correlate with serum bilirubin. The device is for use in the hospital to assist clinicians in monitoring the status of newborn infants for the development of hyperbilirubinemia. 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 Jaundice Meter (JM 103) test results are indicative of hyperbilirubinemia are evaluated by their doctor(s) for appropriate patient management. Bilirubin levels should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations.
This device is not intended for home use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021622: Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021622
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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