510(k) · Cleared
ClearedCanvas Dx
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
Cleared on Apr 11, 2025 as substantially equivalent to DEN200069 (Cognoa, Inc., 2021) after a 144-day review. Its family tree reaches back 1 generation to 2021.
- Decided
- Apr 11, 2025
- Review
- 144 days
- Class
- Class II
- Product code
- QPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200069 (2021). No later device cites it as a predicate yet.
- Root · 1 generation backDEN200069 Cognoa ASD Diagnosis AidCognoa, Inc. · 2021
- This deviceK243558 Canvas DxCognoa, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200069 | Cognoa ASD Diagnosis Aid | Cognoa, Inc. | 2021 | — |
| 0 (this device) | K243558 | Canvas Dx | Cognoa, Inc. | 2025 | — |
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 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
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 |
|---|---|---|---|
| * | DEN200069 | Cognoa ASD Diagnosis AidSummary page 6…ION Canvas Dx is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate DEN200069 Cognoa ASD Diagnosis Aid / Cognoa, Inc. DEVICE DESCRIPTION Canvas Dx is a prescription… | 2021 |
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.
- 1 other device also cites its predicate DEN200069.
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. 2025, 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?
Canvas Dx 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243558 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243558: Canvas Dx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243558
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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