De Novo · Granted
GrantedImmunocap Tryptase, Calibrators, Curve Control, Conjugate 50, Calibrator Strip, Curve Control Strip, Anti-Tryptase
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia US, Inc. · OYL Tryptase Assay System
Granted on Feb 15, 2012 as a new device type through De Novo after a 34-day review. 2 later devices descend from it.
- Decided
- Feb 15, 2012
- Review
- 34 days
- Class
- Class II
- Product code
- OYL
- Recalls
- None
2 later devices descend from it, 2 citing it directly.
- This deviceDEN120001 Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50…Phadia US, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK173704 ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP…Phadia AB · 2018
- Descendant · cites it directly · 0 of its ownK132344 E-Z Check Ozone Test StripsReprocessing Products Corporation (Rpc) · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN120001 | Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50, Calibrator… | Phadia US, Inc. | 2012 | — |
| +1 | K173704 | ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve… | Phadia AB | 2018 | — |
| +1 | K132344 | E-Z Check Ozone Test Strips | Reprocessing Products Corporation (Rpc) | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 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 OYL? 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?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
2 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, K173704 (Phadia AB, 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OYL devicesOYL Tryptase Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OYL
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · OYL
Too few OYL 510(k)s in any year since 2007 to give a median.
Recalls per year · OYL
No recall names OYL since 2007.
Adverse event reports per year · OYL
No MAUDE report names OYL 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 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/DEN120001 · printed Nov 3, 2026
Cite this page
510(k) Report. “DEN120001: Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50, Calibrator Strip, Curve Control Strip, Anti-Tryptase.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/DEN120001
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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