510(k) Report

510(k) · Cleared

Cleared

Opti-Lens Contact Lens Case

K920064510(k) TraditionalCleared Mar 4, 199257-day reviewClass II21 CFR 886.5928

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ryder Intl. Corp. · LRX Case, Contact Lens

Cleared on Mar 4, 1992 after a 57-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 24 later devices descend from it.

Decided
Mar 4, 1992
Review
57 days
Class
Class II
Product code
LRX
Recalls
None
Predicates
0

24 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2007: 1 descendant cleared2013: 3 descendants cleared2012: 3 descendants cleared2011: 2 descendants cleared2010: 1 descendant cleared2016: 2 descendants cleared2023: 1 descendant cleared2014: 3 descendants cleared2024: 1 descendant cleared2017: 3 descendants cleared2015: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK920064 Opti-Lens Contact Lens CaseRyder Intl. Corp. · 1992
  2. Descendant · cites it directly · 23 of its ownK042578 I-Promotions Contact Lens CaseI-Promotions, Inc. · 2005
  3. Descendant · 2 generations on · 17 of its ownK071081 Contact Lens CaseNingbo Kaida Rubber and Plastic Technology Co., LT · 2007
  4. Descendant · 3 generations on · 11 of its ownK093377 Polaris Contact Lens CaseReliance Design & Manufacturing Corp. · 2010
  5. Descendant · 4 generations on · 9 of its ownK120904 Polaris Dial-a-Date Contact Lens CaseReliance Design & Manufacture Corp. · 2012
  6. Descendant · 5 generations on · 5 of its ownK130930 Owl Contact Lens Cases, Dog Contact Lens CasesNingbo Lishunda Electronics Co., Ltd. · 2014

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2005: 12007: 12010: 12011: 22012: 32013: 32014: 32015: 12016: 22017: 32023: 12024: 12025: 12026: 1
2005high 3 (2012) · low 0 (2006)2026

Most influential descendants

Showing 5 of 24 · See all
  • K042578I-Promotions Contact Lens CaseI-Promotions, Inc. · 2005 · cites it directly23descendants
  • K071081Contact Lens CaseNingbo Kaida Rubber and Plastic Technology Co., LT · 2007 · 2 generations on17descendants
  • K093377Polaris Contact Lens CaseReliance Design & Manufacturing Corp. · 2010 · 3 generations on11descendants
  • K120904Polaris Dial-a-Date Contact Lens CaseReliance Design & Manufacture Corp. · 2012 · 4 generations on9descendants
  • K130930Owl Contact Lens Cases, Dog Contact Lens CasesNingbo Lishunda Electronics Co., Ltd. · 2014 · 5 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K920064Opti-Lens Contact Lens CaseRyder Intl. Corp.1992—
+1K042578I-Promotions Contact Lens CaseI-Promotions, Inc.2005—
+2K071081Contact Lens CaseNingbo Kaida Rubber and Plastic Technology Co., LT2007—
+3K093377Polaris Contact Lens CaseReliance Design & Manufacturing Corp.2010—
+4K120904Polaris Dial-a-Date Contact Lens CaseReliance Design & Manufacture Corp.2012—
+5K130930Owl Contact Lens Cases, Dog Contact Lens CasesNingbo Lishunda Electronics Co., Ltd.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
201010
201120
201230
201330
201430
201510
201620
201730
202310
202410
202510
202610
FIG. 1 — Lineage of K920064, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K240095 CAREUS Contact Lens Case (Model 1, Model 2…score 15.4 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (24)

See all 24

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042578I-Promotions Contact Lens CaseI-Promotions, Inc.200523

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, K042578 (I-Promotions, Inc., 2005) has gone furthest, with 23 descendants of its own.

How does its category compare?

All LRX devices

LRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LRX

1in 2025

2007: 12009: 12010: 12011: 22012: 32013: 42014: 32015: 22016: 22017: 52023: 12024: 12025: 12026 (partial year): 1
2007high 5 (2017) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LRX

49in 2017

2012: 103 days median2013: 72 days median2014: 249 days median2017: 49 days median
2007high 249 (2014) · low 49 (2017)2026

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

2012: 12014: 12017: 32021: 1
2007high 3 (2017) · low 0 (2007)2025

MAUDE reports naming product code LRX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20091—00
20101—00
20112—00
2012310301
201347200
2014324901
20152—00
20162—00
201754903
20180—00
20190—00
20200—00
20210—01
20220—00
20231—00
20241—00
20251—00
20261—0—
Cite this page

510(k) Report. “K920064: Opti-Lens 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/K920064

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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