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 Div. Wilmington Partners, L.P. · LRX Case, Contact Lens
Cleared on Jul 12, 1996 as substantially equivalent to K951552 (Polymer Technology Corp., 1995) after a 15-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it.
- Decided
- Jul 12, 1996
- Review
- 15 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951552 (1995). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK951552 Boston Contact Lens CasePolymer Technology Corp. · 1995
- This deviceK962512 Boston Contact Lens CasePolymer Technology Div. Wilmington Partners, L.P. · 1996
- Descendant · cites it directly · 3 of its ownK974635 Paragon Lens CareParagon Vision Sciences · 1998
- Descendant · 2 generations on · 1 of its ownK993486 Paragon Lens CarrierParagon Vision Sciences · 1999
- Descendant · 2 generations on · 1 of its ownK993487 Paragon Lens VialParagon Vision Sciences · 1999
- Descendant · 3 generations on · 0 of its ownK040914 Polyvial/Polypak, Contact Lens Case and Storage System Container for…Exero Products, Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K974635Paragon Lens CareParagon Vision Sciences · 1998 · cites it directly3descendants
- K993486Paragon Lens CarrierParagon Vision Sciences · 1999 · 2 generations on1descendant
- K993487Paragon Lens VialParagon Vision Sciences · 1999 · 2 generations on1descendant
- K040914Polyvial/Polypak, Contact Lens Case and Storage System Container for OphthalmicsExero Products, Inc. · 2004 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951552 | Boston Contact Lens Case | Polymer Technology Corp. | 1995 | — |
| 0 (this device) | K962512 | Boston Contact Lens Case | Polymer Technology Div. Wilmington Partners, L.P. | 1996 | — |
| +1 | K974635 | Paragon Lens Care | Paragon Vision Sciences | 1998 | — |
| +2 | K993486 | Paragon Lens Carrier | Paragon Vision Sciences | 1999 | — |
| +2 | K993487 | Paragon Lens Vial | Paragon Vision Sciences | 1999 | — |
| +3 | 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 |
|---|---|---|
| 1998 | 1 | 0 |
| 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 15.3 · 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 |
|---|---|---|---|
| * | K951552 | Boston Contact Lens CaseSummary page 1…for use with rigid gas permeable contact lenses, The BOSTON Contact Lens Case is substantially equivalent to the following marketed product: BOSTON® Contact Lens Case (K951552) Device Description : The BOSTON® Contact Lens Case is plastic and double-welled with ridged screw caps on the wells. The interi… | 1995 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974635 | Paragon Lens Care | 1998 | 3 |
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.
- Of its descendants, K974635 (Paragon Vision Sciences, 1998) has gone furthest, with 3 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 | — |
What is it indicated for?
The BOSTON Contact Lens Case is indicated for disinfection and storage of rigid gas permeable contact lenses.
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/K962512 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962512: 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/K962512
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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