510(k) · Cleared
ClearedNovavision, Model 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novavision, Inc. · HPT Perimeter, Automatic, Ac-Powered
Cleared on Apr 22, 2003 as substantially equivalent to K911938 (Performance Ent., 1991) and 1 other predicate after a 175-day review. Its family tree reaches back 2 generations to 1984.
- Decided
- Apr 22, 2003
- Review
- 175 days
- Class
- Class I
- Product code
- HPT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K841599 (1984). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K841599 | Storz Universal Eye Shield | Storz Instrument Co. | 1984 | — |
| −1 | K012530 | AA-1 System | Neurovision, Inc. | 2001 | — |
| 0 (this device) | K023623 | Novavision, Model 2.0 | Novavision, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 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 HPT? 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? (2)
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 |
|---|---|---|---|
| * | K911938 | Dynavision 2000Summary page 5…ask Performance Recorder Classification Name Recorder, attention task performance Product code LQD Predicate Devices DynaVision 2000 (K911938) AA-1 System for the Treatment of Amblyopia (K012530) Description NovaVisionTMconsis… | 1991 |
| * | K012530 | AA-1 SystemSummary page 5…rformance Product code LQD Predicate Devices DynaVision 2000 (K911938) AA-1 System for the Treatment of Amblyopia (K012530) Description NovaVisionTMconsists of two computer software programs: (1) one intende… | 2001 |
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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 17.3 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All HPT devicesHPT Perimeter, Automatic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HPT
2in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · HPT
Too few HPT 510(k)s in any year since 2007 to give a median.
Recalls per year · HPT
No recall names HPT since 2007.
Adverse event reports per year · HPT
1in 2023
MAUDE reports naming product code HPT, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 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 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
NovaVisionm is intended for the diagnosis and improvement of visual functions in patients with impaired vision that may result from trauma, stroke, inflammation, surgical removal of brain tumors or brain surgery, and may also be used to improve visual function in patients with amblyopia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023623: Novavision, Model 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023623
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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