510(k) · Cleared
ClearedVisibly Digital Acuity Product
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visibly, Inc. · QTO Digital Visual Acuity Test
Cleared on Aug 12, 2022 as substantially equivalent to K100095 (Vimetrics,Llc., 2010) after a 213-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Aug 12, 2022
- Review
- 213 days
- Class
- Class I
- Product code
- QTO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K100095 (2010). No later device cites it as a predicate yet.
- Root · 1 generation backK100095 Central Vision Analyzer Model 1000Vimetrics,Llc. · 2010
- This deviceK220090 Visibly Digital Acuity ProductVisibly, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K100095 | Central Vision Analyzer Model 1000 | Vimetrics,Llc. | 2010 | — |
| 0 (this device) | K220090 | Visibly Digital Acuity Product | Visibly, Inc. | 2022 | — |
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 QTO? 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.
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.
How does its category compare?
All QTO devicesQTO Digital Visual Acuity Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QTO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QTO
Too few QTO 510(k)s in any year since 2007 to give a median.
Recalls per year · QTO
No recall names QTO since 2007.
Adverse event reports per year · QTO
No MAUDE report names QTO 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 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Visibly Digital Acuity Product (VDAP) is a web-based, self-guided software application intended for use by adults, ages 22 to 40, who have the capability to perform a self-test at home, to aid in the evaluation of visual acuity with or without correction. The software allows users to view and respond to displayed optotypes and uses the responses to categorize a patient’s visual acuity into one of two categories, with an individual output for each…
Read the full statement (163 words)
The Visibly Digital Acuity Product (VDAP) is a web-based, self-guided software application intended for use by adults, ages 22 to 40, who have the capability to perform a self-test at home, to aid in the evaluation of visual acuity with or without correction. The software allows users to view and respond to displayed optotypes and uses the responses to categorize a patient’s visual acuity into one of two categories, with an individual output for each eye:
e TRUE - visual acuity that is consistent with normal vision
e FALSE - visual acuity that is not consistent with normal vision
The Visibly Digital Acuity Product recommendations are intended to be supportive recommendations that will be used by an eye care provider, along with the patient’s medical history and profile, prior corrective eyewear prescriptions, and subjective vision data. The Visibly Digital Acuity Product does not provide screening or diagnosis of eye health or other disease, nor is it intended to replace an in-person eye exam.
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/K220090 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220090: Visibly Digital Acuity Product.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220090
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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