De Novo · Granted
GrantedCognoa ASD Diagnosis Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cognoa, Inc. · QPF Pediatric Autism Spectrum Disorder Diagnosis Aid
Granted on Jun 2, 2021 as a new device type through De Novo after a 211-day review. 5 later devices descend from it.
- Decided
- Jun 2, 2021
- Review
- 211 days
- Class
- Class II
- Product code
- QPF
- Recalls
- None
5 later devices descend from it, 2 citing it directly.
- This deviceDEN200069 Cognoa ASD Diagnosis AidCognoa, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK213882 EarliPoint SystemEarlitec Diagnostics, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK230337 EarliPointEarlitec Diagnostics, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK243891 EarliPoint SystemEarlitec Diagnostics · 2025
- Descendant · 4 generations on · 0 of its ownK253442 EarliPoint AssessmentEarlitec Diagnostics · 2026
- Descendant · cites it directly · 0 of its ownK243558 Canvas DxCognoa, Inc. · 2025
Most influential descendants
Showing 5 of 5 · See all- K213882EarliPoint SystemEarlitec Diagnostics, Inc. · 2022 · cites it directly3descendants
- K230337EarliPointEarlitec Diagnostics, Inc. · 2023 · 2 generations on2descendants
- K243891EarliPoint SystemEarlitec Diagnostics · 2025 · 3 generations on1descendant
- K253442EarliPoint AssessmentEarlitec Diagnostics · 2026 · 4 generations on0descendants
- K243558Canvas DxCognoa, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN200069 | Cognoa ASD Diagnosis Aid | Cognoa, Inc. | 2021 | — |
| +1 | K213882 | EarliPoint System | Earlitec Diagnostics, Inc. | 2022 | — |
| +2 | K230337 | EarliPoint | Earlitec Diagnostics, Inc. | 2023 | — |
| +3 | K243891 | EarliPoint System | Earlitec Diagnostics | 2025 | — |
| +4 | K253442 | EarliPoint Assessment | Earlitec Diagnostics | 2026 | — |
| +1 | K243558 | Canvas Dx | Cognoa, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo 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 QPF? 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 QPF device
- #1 K243891 EarliPoint Systemscore 12.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (5)
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, K213882 (Earlitec Diagnostics, Inc., 2022) has gone furthest, with 3 descendants of its own.
How does its category compare?
All QPF devicesQPF Pediatric Autism Spectrum Disorder Diagnosis Aid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QPF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QPF
Too few QPF 510(k)s in any year since 2007 to give a median.
Recalls per year · QPF
No recall names QPF since 2007.
Adverse event reports per year · QPF
No MAUDE report names QPF 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 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Cognoa ASD Diagnosis Aid is intended for use by healthcare providers as an aid in the diagnosis of Autism Spectrum Disorder (ASD) for patients ages 18 months through 72 months who are at risk for developmental delay based on concerns of a parent, caregiver, or healthcare provider.
The device is not intended for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN200069 · printed Nov 3, 2026
Cite this page
510(k) Report. “DEN200069: Cognoa ASD Diagnosis Aid.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/DEN200069
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026