510(k) · Cleared
ClearedPVS Basic 2; Epic 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon Vision Sciences · HQD Lens, Contact (Other Material) - Daily
Cleared on Apr 25, 2002 as substantially equivalent to K984436 (Paragon Vision Sciences, 1999) after a 203-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Apr 25, 2002
- Review
- 203 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K984436 (1999). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK984436 PVS BasicsParagon Vision Sciences · 1999
- This deviceK013310 PVS Basic 2; Epic 2Paragon Vision Sciences · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984436 | PVS Basics | Paragon Vision Sciences | 1999 | — |
| 0 (this device) | K013310 | PVS Basic 2; Epic 2 | Paragon Vision Sciences | 2002 | — |
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 HQD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HQD device
- #1 K240618 Acuity 200™ (fluoroxyfocon A) Rigid Gas…score 19.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K984436 | PVS BasicsSummary page 2…e PVS Basic™ 2 (mig; afocon the PVS Basics™ Dk 67 rigid gas permeable contact lens marketed by Paragon Vision Sciences which is presently approved for daily wear 510(k), K984436. The physical, optical and chemxcal propemes of PVS Basnc 2 (pa ufocon E) contact lenseé ‘See tablé\;)'f next page. 116 === Pa… | 1999 |
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.
- 1 other device also cites its predicate K984436.
How does its category compare?
All HQD devicesHQD Lens, Contact (Other Material) - Daily: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQD
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HQD
80in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQD
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQD
2in 2025
MAUDE reports naming product code HQD, 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 | 4 | 78 | 0 | 6 |
| 2008 | 5 | 100 | 0 | 8 |
| 2009 | 2 | — | 0 | 12 |
| 2010 | 0 | — | 1 | 2 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 1 | — | 0 | 26 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 7 | 119 | 0 | 1 |
| 2017 | 9 | 66 | 0 | 3 |
| 2018 | 5 | 53 | 0 | 0 |
| 2019 | 2 | — | 0 | 5 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 3 | 123 | 0 | 3 |
| 2022 | 3 | 29 | 0 | 3 |
| 2023 | 3 | 77 | 0 | 8 |
| 2024 | 5 | 80 | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
PVS Basic™ 2 and Epic® 2 rigid gas permeable contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes who are nearsighted (myopic); farsighted (hyperopic); and, who may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. PVS Basic™ 2 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS Basic™ 2 and Epic® 2 bifocal lenses are indicated for presbyopic persons (farsighted or nearsighted) including astigmatic corrections up to +4.00 D requiring add power of up to +4.00 D.
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/K013310 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013310: PVS Basic 2; Epic 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013310
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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