510(k) · Cleared
ClearedSacks Holdings Inc.'S Contact Lens Storage Case
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sacks Holdings, Inc. · LRX Case, Contact Lens
Cleared on Jul 6, 2012 as substantially equivalent to K042578 (I-Promotions, Inc., 2005) after a 92-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Jul 6, 2012
- Review
- 92 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K920064 (1992). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK920064 Opti-Lens Contact Lens CaseRyder Intl. Corp. · 1992
- 1 generation backK042578 I-Promotions Contact Lens CaseI-Promotions, Inc. · 2005
- This deviceK121030 Sacks Holdings Inc.'S Contact Lens Storage CaseSacks Holdings, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK131875 Menicon Nect Contact Lens CaseForesight Regulatory Strategies · 2013
Most influential descendants
Showing 1 of 1 · See all- K131875Menicon Nect Contact Lens CaseForesight Regulatory Strategies · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920064 | Opti-Lens Contact Lens Case | Ryder Intl. Corp. | 1992 | — |
| −1 | K042578 | I-Promotions Contact Lens Case | I-Promotions, Inc. | 2005 | — |
| 0 (this device) | K121030 | Sacks Holdings Inc.'S Contact Lens Storage Case | Sacks Holdings, Inc. | 2012 | — |
| +1 | K131875 | Menicon Nect Contact Lens Case | Foresight Regulatory Strategies | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K042578 | I-Promotions Contact Lens CaseSummary page 1…: i-Promotions, Inc. Classification Name: Case, Contact Lens Device Class 11I Prod uct Code: LRX Regulation Number: 886.5928 510(k) Number: K042578 4.0 Device Description: The applicant contact lens case is a lens care product used by the contact lens wearer or p… | 2005 |
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 |
|---|---|---|---|
| K131875 | Menicon Nect Contact Lens Case | 2013 | 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 20 years and passes through 3 companies; a new generation was cleared every 12.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K131875 (Foresight Regulatory Strategies, 2013) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K042578.
How does its category compare?
All LRX devicesLRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
For storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. For use during chemical disinfection only. Not to be used with heat.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121030: Sacks Holdings Inc.'S Contact Lens Storage Case.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121030
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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