510(k) · Cleared
ClearedEonis™ SMA kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Revvity, Inc. · QUE Spinal Muscular Atrophy Newborn Screening Test System
Cleared on Sep 30, 2026 as substantially equivalent to DEN200044 (Perkinelmer, Inc., 2022) after a 44-day review. Its family tree reaches back 1 generation to 2022.
- Decided
- Sep 30, 2026
- Review
- 44 days
- Class
- Class II
- Product code
- QUE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200044 (2022). No later device cites it as a predicate yet.
- Root · 1 generation backDEN200044 Eonis SCID-SMA KitPerkinelmer, Inc. · 2022
- This deviceK262893 Eonis™ SMA kitRevvity, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200044 | Eonis SCID-SMA Kit | Perkinelmer, Inc. | 2022 | — |
| 0 (this device) | K262893 | Eonis™ SMA kit | Revvity, Inc. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QUE? 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN200044 | Eonis SCID-SMA KitSummary page 5…cular Atrophy Newborn Screening Test System Classification: Immunology Product Code: QUE Predicate Device: Eonis SCID-SMA kit (DEN200044) Intended Use: Pg.1 of 9… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All QUE devicesQUE Spinal Muscular Atrophy Newborn Screening Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QUE
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QUE
Too few QUE 510(k)s in any year since 2007 to give a median.
Recalls per year · QUE
No recall names QUE since 2007.
Adverse event reports per year · QUE
No MAUDE report names QUE 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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Eonis™ SMA kit is intended for the qualitative detection of the SMN1 gene exon 7 as an aid in screening newborns for Spinal Muscular Atrophy (SMA). The test is intended for DNA from blood specimens dried on a filter paper and for use on the Eonis Q or QuantStudio™ Dx Real-Time PCR instrument.
This test is only intended for use for screening of SMA that bear the homozygous deletion of SMN1 exon 7.
This test is not intended for use as a diagnostic test and a positive screening result should be followed by confirmatory testing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262893 · printed Nov 4, 2026
Cite this page
510(k) Report. “K262893: Eonis™ SMA kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K262893
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026