510(k) · Cleared
ClearedEarliPoint Assessment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Earlitec Diagnostics · QPF Pediatric Autism Spectrum Disorder Diagnosis Aid
Cleared on Mar 5, 2026 as substantially equivalent to K243891 (Earlitec Diagnostics, 2025) after a 155-day review. Its family tree reaches back 4 generations to 2021.
- Decided
- Mar 5, 2026
- Review
- 155 days
- Class
- Class II
- Product code
- QPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN200069 (2021). No later device cites it as a predicate yet.
- Root · 4 generations backDEN200069 Cognoa ASD Diagnosis AidCognoa, Inc. · 2021
- 3 generations backK213882 EarliPoint SystemEarlitec Diagnostics, Inc. · 2022
- 2 generations backK230337 EarliPointEarlitec Diagnostics, Inc. · 2023
- 1 generation backK243891 EarliPoint SystemEarlitec Diagnostics · 2025
- This deviceK253442 EarliPoint AssessmentEarlitec Diagnostics · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN200069 | Cognoa ASD Diagnosis Aid | Cognoa, Inc. | 2021 | — |
| −3 | K213882 | EarliPoint System | Earlitec Diagnostics, Inc. | 2022 | — |
| −2 | K230337 | EarliPoint | Earlitec Diagnostics, Inc. | 2023 | — |
| −1 | K243891 | EarliPoint System | Earlitec Diagnostics | 2025 | — |
| 0 (this device) | K253442 | EarliPoint Assessment | Earlitec Diagnostics | 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 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 |
|---|---|---|---|
| * | K243891 | EarliPoint SystemSummary page 5…ss: II Panel: Neurology Devices Panel Product Code: QPF Predicate Device EarliPoint System K243891 Device Description The EarliPoint assessment uses an eye tracker to measure the pat… | 2025 |
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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 4 ancestors has a recall.
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. 2026, 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 EarliPoint Assessment device is indicated as a tool to aid qualified clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) in children ages 16 months through 95 months (7 years), who are at risk based on concerns identified by a parent, caregiver, or healthcare provider.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253442: EarliPoint Assessment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253442
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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