PMA · Approved
ApprovedJaundice Meter 101
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Narco Scientific · LMX (no longer in FDA’s product-code list)
Approved on Nov 20, 1981 through premarket approval, which rests on the device’s own clinical evidence after a 260-day review. 2 of the 5 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Nov 20, 1981
- Review
- 260 days
- Class
- Class III
- Product code
- LMX
- Recalls
- None
4 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.
- This deviceP810007 Jaundice Meter 101Narco Scientific · 1981
- Descendant · cites it directly · 3 of its ownK972309 JM-102 Jaundice MeterAir-Shields, Inc. · 1998
- Descendant · 2 generations on · 2 of its ownK021622 Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103Hill-Rom Air-Shields · 2003
- Descendant · 3 generations on · 1 of its ownK042522 Jaundice Meter, Model JM 103Draeger Medical Infant Care, Inc. · 2005 · Recalled (Class I)
- Descendant · 4 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 4 of 4 · See all- K972309JM-102 Jaundice MeterAir-Shields, Inc. · 1998 · cites it directly3descendants
- K021622Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103Hill-Rom Air-Shields · 2003 · 2 generations on2descendants
- K042522Jaundice Meter, Model JM 103Draeger Medical Infant Care, Inc. · 2005 · 3 generations on1descendant
- K133175Draeger Jaundice Meter JM-105Draeger Medical Systems, Inc. · 2014 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P810007 | Jaundice Meter 101 | Narco Scientific | 1981 | — |
| +1 | 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 | — |
| +3 | K042522 | Jaundice Meter, Model JM 103 | Draeger Medical Infant Care, Inc. | 2005 | Class I |
| +4 | 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 |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 1 |
| 2014 | 1 | 1 |
Sources: FDA PMA database (decision fields and supplements), 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972309 | JM-102 Jaundice Meter | 1998 | 3 |
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 · 3 generations on · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
- K133175Draeger Jaundice Meter JM-105Draeger Medical Systems, Inc. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K972309 (Air-Shields, Inc., 1998) has gone furthest, with 3 descendants of its own.
https://510kreport.com/device/P810007 · printed Nov 4, 2026
Cite this page
510(k) Report. “P810007: Jaundice Meter 101.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P810007
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026