510(k) · Cleared
Recalled · 2004Neonatal Chemistry System, Galactose Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isolab, Inc. · JIA Enzymatic Methods, Galactose
Cleared on Feb 1, 1996 after a 363-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 5 times.
- Decided
- Feb 1, 1996
- Review
- 363 days
- Class
- Class I
- Product code
- JIA
- Recalls
- 5
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JIA? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 9, 2004 | Not classified | Z-0515-04 | Other | The device is not stable throughout its labeled expiration date. |
| Jan 9, 2004 | Not classified | Z-0514-04 | Other | The device is not stable throughout its labeled expiration date. |
| May 30, 2003 | Not classified | Z-0971-03 | Other | The device is not stable throughout its labeled expiration date. |
| May 30, 2003 | Not classified | Z-0969-03 | Other | The device is not stable throughout its labeled expiration date. |
| May 30, 2003 | Not classified | Z-0970-03 | Other | The device is not stable throughout its labeled expiration date. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All JIA devicesJIA Enzymatic Methods, Galactose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIA
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JIA
Too few JIA 510(k)s in any year since 2007 to give a median.
Recalls per year · JIA
No recall names JIA since 2007.
Adverse event reports per year · JIA
No MAUDE report names JIA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K950481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950481: Neonatal Chemistry System, Galactose Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950481
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026