510(k) · Cleared
ClearedCentral Vision Analyzer Model 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vimetrics,Llc. · HOX Chart, Visual Acuity
Cleared on May 10, 2010 after a 117-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- May 10, 2010
- Review
- 117 days
- Class
- Class I
- Product code
- HOX
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK100095 Central Vision Analyzer Model 1000Vimetrics,Llc. · 2010
- Descendant · cites it directly · 0 of its ownK220090 Visibly Digital Acuity ProductVisibly, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220090Visibly Digital Acuity ProductVisibly, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K100095 | Central Vision Analyzer Model 1000 | Vimetrics,Llc. | 2010 | — |
| +1 | K220090 | Visibly Digital Acuity Product | Visibly, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 HOX? 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 |
|---|---|---|---|
| * | — | ETDRS, 3 meter, logMAR 0.1, Sloan Letter translucent charts (Precision Vision) Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220090 | Visibly Digital Acuity Product | 2022 | 0 |
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, K220090 (Visibly, Inc., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HOX devicesHOX Chart, Visual Acuity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HOX
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · HOX
Too few HOX 510(k)s in any year since 2007 to give a median.
Recalls per year · HOX
No recall names HOX since 2007.
Adverse event reports per year · HOX
1in 2018
MAUDE reports naming product code HOX, not matched to any one device; reports are not rates.
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 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 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 CVA-1000 is intended for use under the direct supervision of an ophthalmologist or optometrist in the measurement of vision at fixation in one or both eyes, with or without optical correction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100095: Central Vision Analyzer Model 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100095
Report an extraction error
Are you the manufacturer?
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