510(k) · Cleared
ClearedAutodelfia Neonatal Irt Kit, Model B005-112
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wallac OY · CGZ Electrode, Ion-Specific, Chloride
Cleared on Feb 12, 2001 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 12, 2001
- Review
- 76 days
- Class
- Class II
- Product code
- CGZ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK003668 Autodelfia Neonatal Irt Kit, Model B005-112Wallac OY · 2001
- Descendant · cites it directly · 0 of its ownK110274 Autodelfia Neonatal Irt KitWallac Oy, A Subsidiary of Perkinelmer, Inc. · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK102419 GSP Neonatal Irt Kit (3306-001U)Wallac Oy, Subsidiary of Perkinelmer · 2010
- Descendant · cites it directly · 0 of its ownK070889 Autodelfia Neonatal Irt L Kit, Model B022-112Wallac OY · 2008
Most influential descendants
Showing 3 of 3 · See all- K110274Autodelfia Neonatal Irt KitWallac Oy, A Subsidiary of Perkinelmer, Inc. · 2011 · cites it directly0descendants
- K102419GSP Neonatal Irt Kit (3306-001U)Wallac Oy, Subsidiary of Perkinelmer · 2010 · cites it directly0descendants
- K070889Autodelfia Neonatal Irt L Kit, Model B022-112Wallac OY · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003668 | Autodelfia Neonatal Irt Kit, Model B005-112 | Wallac OY | 2001 | — |
| +1 | K110274 | Autodelfia Neonatal Irt Kit | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2011 | 1 |
| +1 | K102419 | GSP Neonatal Irt Kit (3306-001U) | Wallac Oy, Subsidiary of Perkinelmer | 2010 | — |
| +1 | K070889 | Autodelfia Neonatal Irt L Kit, Model B022-112 | Wallac OY | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
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 CGZ? 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K110274 (Wallac Oy, A Subsidiary of Perkinelmer, Inc., 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CGZ devicesCGZ Electrode, Ion-Specific, Chloride: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGZ
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · CGZ
Too few CGZ 510(k)s in any year since 2007 to give a median.
Recalls per year · CGZ
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGZ
5in 2025
MAUDE reports naming product code CGZ, 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 | 1 | — | 1 | 4 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 5 |
| 2012 | 0 | — | 0 | 30 |
| 2013 | 0 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 19 |
| 2019 | 0 | — | 2 | 3 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K003668 · printed Nov 5, 2026
Cite this page
510(k) Report. “K003668: Autodelfia Neonatal Irt Kit, Model B005-112.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003668
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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