510(k) · Cleared
ClearedParagon Lens Care
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 Feb 4, 1998 as substantially equivalent to K962512 (Polymer Technology Div. Wilmington Partners, L.P., 1996) after a 54-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- Feb 4, 1998
- Review
- 54 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K951552 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK951552 Boston Contact Lens CasePolymer Technology Corp. · 1995
- 1 generation backK962512 Boston Contact Lens CasePolymer Technology Div. Wilmington Partners, L.P. · 1996
- This deviceK974635 Paragon Lens CareParagon Vision Sciences · 1998
- Descendant · cites it directly · 1 of its ownK993486 Paragon Lens CarrierParagon Vision Sciences · 1999
- Descendant · cites it directly · 1 of its ownK993487 Paragon Lens VialParagon Vision Sciences · 1999
- Descendant · 2 generations on · 0 of its ownK040914 Polyvial/Polypak, Contact Lens Case and Storage System Container for…Exero Products, Inc. · 2004
Most influential descendants
Showing 3 of 3 · See all- K993486Paragon Lens CarrierParagon Vision Sciences · 1999 · cites it directly1descendant
- K993487Paragon Lens VialParagon Vision Sciences · 1999 · cites it directly1descendant
- K040914Polyvial/Polypak, Contact Lens Case and Storage System Container for OphthalmicsExero Products, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951552 | Boston Contact Lens Case | Polymer Technology Corp. | 1995 | — |
| −1 | K962512 | Boston Contact Lens Case | Polymer Technology Div. Wilmington Partners, L.P. | 1996 | — |
| 0 (this device) | K974635 | Paragon Lens Care | Paragon Vision Sciences | 1998 | — |
| +1 | K993486 | Paragon Lens Carrier | Paragon Vision Sciences | 1999 | — |
| +1 | K993487 | Paragon Lens Vial | Paragon Vision Sciences | 1999 | — |
| +2 | 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 |
|---|---|---|
| 1999 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K962512 | Boston Contact Lens CaseSummary page 1…cnt Lo the Boston Contact Lens Case marketed by Polymer Technology, Division of Wilmington Partners which is presently approved and marketed under premarket notification k962512 In support of the premarket nolification information from the following was submitted: 1. Systemic Injection Test 2. Eye Irrit… | 1996 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K993486 (Paragon Vision Sciences, 1999) has gone furthest, with 1 descendant of its own.
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 Contact Lens Case 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/K974635 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974635: Paragon Lens Care.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974635
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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