De Novo · Granted
GrantedNeogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model MS-8970
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perkinelmer Life Sciences, Inc. · NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Granted on Aug 24, 2004 as a new device type through De Novo after a 53-day review. 4 later devices descend from it.
- Decided
- Aug 24, 2004
- Review
- 53 days
- Class
- Class II
- Product code
- NQL
- Recalls
- None
4 later devices descend from it, 1 citing it directly.
- This deviceDEN040002 Neogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit…Perkinelmer Life Sciences, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK083130 Neobase Non-Derivatized MSMS Kit, Model 3040Perkinelmer, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 2 of its ownK093916 Neobase Non-Derivatized MSMS Kit Model 3040-001UPerkinelmer, Inc. · 2010
- Descendant · 3 generations on · 1 of its ownK173568 NeoBase 2 Non-derivatized MSMS KitWallac Oy, Subsidiary of Perkinelmer, Inc. · 2018
- Descendant · 4 generations on · 0 of its ownK193103 NeoBase 2 Non-derivatized MSMS KitPerkinelmer, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K083130Neobase Non-Derivatized MSMS Kit, Model 3040Perkinelmer, Inc. · 2009 · cites it directly3descendants
- K093916Neobase Non-Derivatized MSMS Kit Model 3040-001UPerkinelmer, Inc. · 2010 · 2 generations on2descendants
- K173568NeoBase 2 Non-derivatized MSMS KitWallac Oy, Subsidiary of Perkinelmer, Inc. · 2018 · 3 generations on1descendant
- K193103NeoBase 2 Non-derivatized MSMS KitPerkinelmer, Inc. · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN040002 | Neogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model… | Perkinelmer Life Sciences, Inc. | 2004 | — |
| +1 | K083130 | Neobase Non-Derivatized MSMS Kit, Model 3040 | Perkinelmer, Inc. | 2009 | 2 |
| +2 | K093916 | Neobase Non-Derivatized MSMS Kit Model 3040-001U | Perkinelmer, Inc. | 2010 | — |
| +3 | K173568 | NeoBase 2 Non-derivatized MSMS Kit | Wallac Oy, Subsidiary of Perkinelmer, Inc. | 2018 | — |
| +4 | K193103 | NeoBase 2 Non-derivatized MSMS Kit | Perkinelmer, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA De Novo 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 NQL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NQL device
- #1 K193103 NeoBase 2 Non-derivatized MSMS Kitscore -0.3 · 4 generations · no Class I recall
Does it have a predicate?
De Novo 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 |
|---|---|---|---|
| K083130 | Neobase Non-Derivatized MSMS Kit, Model 3040 | 2009 | 3 |
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, K083130 (Perkinelmer, Inc., 2009) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NQL devicesNQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NQL
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · NQL
Too few NQL 510(k)s in any year since 2007 to give a median.
Recalls per year · NQL
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQL
1in 2025
MAUDE reports naming product code NQL, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN040002 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN040002: Neogram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model MS-8970.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN040002
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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