510(k) · Cleared
ClearedParagon Lens Vial
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon Vision Sciences · LRX Case, Contact Lens
Cleared on Dec 22, 1999 as substantially equivalent to K974635 (Paragon Vision Sciences, 1998) after a 68-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Dec 22, 1999
- Review
- 68 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K951552 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK951552 Boston Contact Lens CasePolymer Technology Corp. · 1995
- 2 generations backK962512 Boston Contact Lens CasePolymer Technology Div. Wilmington Partners, L.P. · 1996
- 1 generation backK974635 Paragon Lens CareParagon Vision Sciences · 1998
- This deviceK993487 Paragon Lens VialParagon Vision Sciences · 1999
- Descendant · cites it directly · 0 of its ownK040914 Polyvial/Polypak, Contact Lens Case and Storage System Container for…Exero Products, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K040914Polyvial/Polypak, Contact Lens Case and Storage System Container for OphthalmicsExero Products, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951552 | Boston Contact Lens Case | Polymer Technology Corp. | 1995 | — |
| −2 | K962512 | Boston Contact Lens Case | Polymer Technology Div. Wilmington Partners, L.P. | 1996 | — |
| −1 | K974635 | Paragon Lens Care | Paragon Vision Sciences | 1998 | — |
| 0 (this device) | K993487 | Paragon Lens Vial | Paragon Vision Sciences | 1999 | — |
| +1 | K040914 | Polyvial/Polypak, Contact Lens Case and Storage System Container for Ophthalmics | Exero Products, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 LRX? 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 LRX device
- #1 K240095 CAREUS Contact Lens Case (Model 1, Model 2…score 15.4 · 5 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 |
|---|---|---|---|
| * | K974635 | Paragon Lens CareSummary page 1…Paragon Lens Vial is substantially equivalent to the Paragon Contact Lens Case marketed by Paragon Vision Sciences which is presently approved and marketed under 510k # K974635. In support of the premarket notification information the following is submitted. 1. Eye Irritation Test 2. Cytotoxicity Test 3… | 1998 |
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 |
|---|---|---|---|
| K040914 | Polyvial/Polypak, Contact Lens Case and Storage System Container for Ophthalmics | 2004 | 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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K040914 (Exero Products, Inc., 2004) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K974635.
How does its category compare?
All LRX devicesLRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRX
49in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRX
No recall names LRX since 2007.
Adverse event reports per year · LRX
1in 2021
MAUDE reports naming product code LRX, 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 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 3 | 103 | 0 | 1 |
| 2013 | 4 | 72 | 0 | 0 |
| 2014 | 3 | 249 | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 5 | 49 | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Paragon Lens Vial is indicated for storage of rigid gas permeable
and hard contact lenses during chemical disinfection.
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/K993487 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993487: Paragon Lens Vial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993487
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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