510(k) · Cleared
ClearedBoston Contact Lens Case
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymer Technology Corp. · LRX Case, Contact Lens
Cleared on Jun 26, 1995 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jun 26, 1995
- Review
- 83 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK951552 Boston Contact Lens CasePolymer Technology Corp. · 1995
- Descendant · cites it directly · 4 of its ownK962512 Boston Contact Lens CasePolymer Technology Div. Wilmington Partners, L.P. · 1996
- Descendant · 2 generations on · 3 of its ownK974635 Paragon Lens CareParagon Vision Sciences · 1998
- Descendant · 3 generations on · 1 of its ownK993486 Paragon Lens CarrierParagon Vision Sciences · 1999
- Descendant · 3 generations on · 1 of its ownK993487 Paragon Lens VialParagon Vision Sciences · 1999
- Descendant · 4 generations on · 0 of its ownK040914 Polyvial/Polypak, Contact Lens Case and Storage System Container for…Exero Products, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K962512Boston Contact Lens CasePolymer Technology Div. Wilmington Partners, L.P. · 1996 · cites it directly4descendants
- K974635Paragon Lens CareParagon Vision Sciences · 1998 · 2 generations on3descendants
- K993486Paragon Lens CarrierParagon Vision Sciences · 1999 · 3 generations on1descendant
- K993487Paragon Lens VialParagon Vision Sciences · 1999 · 3 generations on1descendant
- K040914Polyvial/Polypak, Contact Lens Case and Storage System Container for OphthalmicsExero Products, Inc. · 2004 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951552 | Boston Contact Lens Case | Polymer Technology Corp. | 1995 | — |
| +1 | K962512 | Boston Contact Lens Case | Polymer Technology Div. Wilmington Partners, L.P. | 1996 | — |
| +2 | K974635 | Paragon Lens Care | Paragon Vision Sciences | 1998 | — |
| +3 | K993486 | Paragon Lens Carrier | Paragon Vision Sciences | 1999 | — |
| +3 | K993487 | Paragon Lens Vial | Paragon Vision Sciences | 1999 | — |
| +4 | 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 |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962512 | Boston Contact Lens Case | 1996 | 4 |
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?
- Of its descendants, K962512 (Polymer Technology Div. Wilmington Partners, L.P., 1996) has gone furthest, with 4 descendants 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 | — |
https://510kreport.com/device/K951552 · printed Nov 5, 2026
Cite this page
510(k) Report. “K951552: Boston Contact Lens Case.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951552
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026