510(k) · Cleared
ClearedEarliPoint System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Earlitec Diagnostics, Inc. · QPF Pediatric Autism Spectrum Disorder Diagnosis Aid
Cleared on Jun 8, 2022 as substantially equivalent to DEN200069 (Cognoa, Inc., 2021) after a 177-day review. Its family tree reaches back 1 generation to 2021. 3 later devices descend from it.
- Decided
- Jun 8, 2022
- Review
- 177 days
- Class
- Class II
- Product code
- QPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200069 (2021). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN200069 Cognoa ASD Diagnosis AidCognoa, Inc. · 2021
- This deviceK213882 EarliPoint SystemEarlitec Diagnostics, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK230337 EarliPointEarlitec Diagnostics, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK243891 EarliPoint SystemEarlitec Diagnostics · 2025
- Descendant · 3 generations on · 0 of its ownK253442 EarliPoint AssessmentEarlitec Diagnostics · 2026
Most influential descendants
Showing 3 of 3 · See allView 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) | K213882 | EarliPoint System | Earlitec Diagnostics, Inc. | 2022 | — |
| +1 | K230337 | EarliPoint | Earlitec Diagnostics, Inc. | 2023 | — |
| +2 | K243891 | EarliPoint System | Earlitec Diagnostics | 2025 | — |
| +3 | K253442 | EarliPoint Assessment | Earlitec Diagnostics | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 4…21 CFR 882.1491 Regulatory Class: II Product Code: QPF 3 PREDICATE DEVICE Predicate Device: Cognoa ASD Diagnosis Aid (DEN200069) Technological Reference: 2D VOG – Video-Oculography (K972243) 4 DEVICE DESCRIPTION The EarliPoint System is a medical… | 2021 |
| † | K972243 | 2D Vog - Video-Oculography | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230337 | EarliPoint | 2023 | 2 |
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?
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. 2022, 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 System is indicated for use in specialized developmental disabilities centers as a tool to aid clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) for patients ages 16 months through 30 months.
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/K213882 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213882: EarliPoint System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213882
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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