510(k) · Cleared
ClearedChromagen V3.0 Reading Aid & Color Discrimination Enhancement Spectacle Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cantor & Nissel, Ltd. · NJH Lens, Spectacle (Prescription), For Reading Discomfort
Cleared on Oct 7, 2002 as substantially equivalent to K012132 (Cantor & Nissel, Ltd., 2002) and 1 other predicate after a 77-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Oct 7, 2002
- Review
- 77 days
- Class
- Class I
- Product code
- NJH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K990757 (1999). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK990757 Cantor & Silver 5X Tinted (Hioxifilcon a) Soft (Spherical & Toric)…Cantor & Silver, Ltd. · 1999
- 1 generation backK012132 Chromagen V3.0 Reading Aid Soft Contact LensCantor & Nissel, Ltd. · 2002
- This deviceK022373 Chromagen V3.0 Reading Aid & Color Discrimination Enhancement…Cantor & Nissel, Ltd. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K990757 | Cantor & Silver 5X Tinted (Hioxifilcon a) Soft (Spherical & Toric) Daily Wear… | Cantor & Silver, Ltd. | 1999 | — |
| −1 | K012132 | Chromagen V3.0 Reading Aid Soft Contact Lens | Cantor & Nissel, Ltd. | 2002 | — |
| 0 (this device) | K022373 | Chromagen V3.0 Reading Aid & Color Discrimination Enhancement Spectacle Lens | Cantor & Nissel, Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 NJH? 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 |
|---|---|---|---|
| * | K012132 | Chromagen V3.0 Reading Aid Soft Contact LensSummary page 3…not required for the spectacle version of the ChromaGen ~ 3 . 0Reading Aid & Color Discrimination Enhancement product line, as efficacy has been established in K994320 & K012132. Table of Substantial Equivalence ChmmaGen Readi… | 2002 |
| * | K994320 | Chromagen V2.0 Haploscopic System & Color Vision Enhancement Soft Contact LensesSummary page 1…& Color Discrimination Enhancement Spectacle Lenses Reason for 5 1 O(k) submission: Expanded Device classification to K994320 & KO12132 Classification Name: Prescription Spectacle lens ChromaGen v3.0 Reading Aid and Color Discrimina… | 2000 |
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 3 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All NJH devicesNJH Lens, Spectacle (Prescription), For Reading Discomfort: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NJH
FDA has decided no NJH device since 2007.
Median 510(k) review, days · NJH
Too few NJH 510(k)s in any year since 2007 to give a median.
Recalls per year · NJH
No recall names NJH since 2007.
Adverse event reports per year · NJH
1in 2017
MAUDE reports naming product code NJH, 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 | 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 | 1 |
| 2018 | 0 | — | 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?
Prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons.
Prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.
Prescribed to enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022373 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022373: Chromagen V3.0 Reading Aid & Color Discrimination Enhancement Spectacle Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022373
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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