510(k) · Cleared
ClearedEarliPoint
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 29, 2023 as substantially equivalent to K213882 (Earlitec Diagnostics, Inc., 2022) after a 142-day review. Its family tree reaches back 2 generations to 2021. 2 later devices descend from it.
- Decided
- Jun 29, 2023
- Review
- 142 days
- Class
- Class II
- Product code
- QPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN200069 (2021). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN200069 Cognoa ASD Diagnosis AidCognoa, Inc. · 2021
- 1 generation backK213882 EarliPoint SystemEarlitec Diagnostics, Inc. · 2022
- This deviceK230337 EarliPointEarlitec Diagnostics, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK243891 EarliPoint SystemEarlitec Diagnostics · 2025
- Descendant · 2 generations on · 0 of its ownK253442 EarliPoint AssessmentEarlitec Diagnostics · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN200069 | Cognoa ASD Diagnosis Aid | Cognoa, Inc. | 2021 | — |
| −1 | K213882 | EarliPoint System | Earlitec Diagnostics, Inc. | 2022 | — |
| 0 (this device) | K230337 | EarliPoint | Earlitec Diagnostics, Inc. | 2023 | — |
| +1 | K243891 | EarliPoint System | Earlitec Diagnostics | 2025 | — |
| +2 | K253442 | EarliPoint Assessment | Earlitec Diagnostics | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K213882 | EarliPoint SystemSummary page 4…Pediatric Autism Spectrum Disorder Diagnostic Aid Device Trade Name EarliPoint System Predicate Device Name EarliPoint System (K213882) 510(k) Submitter: Thomas Ressemann, CEO EarliTec Diagnostics, Inc.… | 2022 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243891 | EarliPoint System | 2025 | 1 |
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 2 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K243891 (Earlitec Diagnostics, 2025) has gone furthest, with 1 descendant 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. 2023, 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 ASD patients ages 16 months through 30 months
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230337: EarliPoint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230337
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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