510(k) · Cleared
ClearedMascular Computerized Psychophysical Test (MCPT)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Notal Vision, Inc. · HOQ Grid, Amsler
Cleared on Mar 4, 2002 after an 87-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Mar 4, 2002
- Review
- 87 days
- Class
- Class I
- Product code
- HOQ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK014044 Mascular Computerized Psychophysical Test (MCPT)Notal Vision, Inc. · 2002
- Descendant · cites it directly · 5 of its ownK050350 The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview…Notal Vision, Inc. · 2005
- Descendant · 2 generations on · 4 of its ownK091579 Foresee HomeNotal Vision, Ltd. · 2009
- Descendant · 3 generations on · 3 of its ownK121738 Myvisiontrack (TM)Vital Art and Science Incorporated · 2013
- Descendant · 4 generations on · 2 of its ownK143211 myVision Track Model 005Vital Art and Science Incorporated · 2015
- Descendant · 5 generations on · 1 of its ownK180895 AlleyeOculocare Medical AG · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K050350The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview PHP)Notal Vision, Inc. · 2005 · cites it directly5descendants
- K091579Foresee HomeNotal Vision, Ltd. · 2009 · 2 generations on4descendants
- K121738Myvisiontrack (TM)Vital Art and Science Incorporated · 2013 · 3 generations on3descendants
- K143211myVision Track Model 005Vital Art and Science Incorporated · 2015 · 4 generations on2descendants
- K180895AlleyeOculocare Medical AG · 2018 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K014044 | Mascular Computerized Psychophysical Test (MCPT) | Notal Vision, Inc. | 2002 | — |
| +1 | K050350 | The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview PHP) | Notal Vision, Inc. | 2005 | — |
| +2 | K091579 | Foresee Home | Notal Vision, Ltd. | 2009 | — |
| +3 | K121738 | Myvisiontrack (TM) | Vital Art and Science Incorporated | 2013 | — |
| +4 | K143211 | myVision Track Model 005 | Vital Art and Science Incorporated | 2015 | — |
| +5 | K180895 | Alleye | Oculocare Medical AG | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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 HOQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Amsler Grid Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050350 | The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview PHP) | 2005 | 5 |
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, K050350 (Notal Vision, Inc., 2005) has gone furthest, with 5 descendants of its own.
How does its category compare?
All HOQ devicesHOQ Grid, Amsler: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HOQ
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · HOQ
Too few HOQ 510(k)s in any year since 2007 to give a median.
Recalls per year · HOQ
No recall names HOQ since 2007.
Adverse event reports per year · HOQ
No MAUDE report names HOQ 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 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Notal Vision Macular Computerized Psychophysical Test (MCPT) is indicated for the early detection of central and paracentral irregularities (visual abnormalities) in the visual field, most commonly associated with macular degeneration.
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/K014044 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014044: Mascular Computerized Psychophysical Test (MCPT).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014044
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026