510(k) · Cleared
ClearedJM-102 Jaundice Meter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Air-Shields, Inc. · MQM Bilirubin (Total And Unbound) In The Neonate Test System
Cleared on Sep 22, 1998 as substantially equivalent to P810007 (Narco Scientific, 1981) after a 459-day review. Its family tree reaches back 1 generation to 1981. 2 of the 5 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Sep 22, 1998
- Review
- 459 days
- Class
- Class I
- Product code
- MQM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P810007 (1981). 3 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 · 1 generation backP810007 Jaundice Meter 101Narco Scientific · 1981
- This deviceK972309 JM-102 Jaundice MeterAir-Shields, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK021622 Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103Hill-Rom Air-Shields · 2003
- Descendant · 2 generations on · 1 of its ownK042522 Jaundice Meter, Model JM 103Draeger Medical Infant Care, Inc. · 2005 · Recalled (Class I)
- Descendant · 3 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 3 of 3 · See all- K021622Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103Hill-Rom Air-Shields · 2003 · cites it directly2descendants
- K042522Jaundice Meter, Model JM 103Draeger Medical Infant Care, Inc. · 2005 · 2 generations on1descendant
- K133175Draeger Jaundice Meter JM-105Draeger Medical Systems, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P810007 | Jaundice Meter 101 | Narco Scientific | 1981 | — |
| 0 (this device) | 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 | — |
| +2 | K042522 | Jaundice Meter, Model JM 103 | Draeger Medical Infant Care, Inc. | 2005 | Class I |
| +3 | 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 |
|---|---|---|
| 2003 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | P810007 | Jaundice Meter 101Summary page 1…Prepared: June 19, 1997 A. LEGALLY MARKETED PREDICATE DEVICES The JM-102 -Jaundice Meter is substantially equivalent to an earlier model of the same device, the JM-101 (P810007). B. DEVICE DESCRIPTION The Air-Shields JM-102 Jaundice Meter is a hand-held non-invasive device for the measurement of the lev… | 1981 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021622 | Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103 | 2003 | 2 |
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 · 2 generations on · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
- K133175Draeger Jaundice Meter JM-105Draeger Medical Systems, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K021622 (Hill-Rom Air-Shields, 2003) has gone furthest, with 2 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 JM-102 Jaundice Meter provides an objective index of icterus in infants and when used in conjunction with other clinical signs and/or laboratory measurements, can assist the physician in making clinical decisions regarding the need for serum bilirubin measurements.
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/K972309 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972309: JM-102 Jaundice Meter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972309
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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