510(k) Report

510(k) · Cleared

Cleared

Owl Contact Lens Cases, Dog Contact Lens Cases

K130930510(k) TraditionalCleared Feb 12, 2014314-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

Ningbo Lishunda Electronics Co., Ltd. · LRX Case, Contact Lens

Cleared on Feb 12, 2014 as substantially equivalent to K120904 (Reliance Design & Manufacture Corp., 2012) after a 314-day review. Its family tree reaches back 5 generations to 1992. 5 later devices descend from it.

Decided
Feb 12, 2014
Review
314 days
Class
Class II
Product code
LRX
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K920064 (1992). 6 ancestors in all. 5 later devices descend from it, 3 citing it directly.

  1. Root · 5 generations backK920064 Opti-Lens Contact Lens CaseRyder Intl. Corp. · 1992
  2. 4 generations backK042578 I-Promotions Contact Lens CaseI-Promotions, Inc. · 2005
  3. 3 generations backK071081 Contact Lens CaseNingbo Kaida Rubber and Plastic Technology Co., LT · 2007
  4. 2 generations backK093377 Polaris Contact Lens CaseReliance Design & Manufacturing Corp. · 2010
  5. 1 generation backK120904 Polaris Dial-a-Date Contact Lens CaseReliance Design & Manufacture Corp. · 2012
  6. This deviceK130930 Owl Contact Lens Cases, Dog Contact Lens CasesNingbo Lishunda Electronics Co., Ltd. · 2014
  7. Descendant · cites it directly · 2 of its ownK142717 Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact…Ni Hau Industrial Co., Ltd. · 2015
  8. Descendant · 2 generations on · 1 of its ownK162869 Contact Lens CaseNingbo Yinzhou Zonghai Artware Co., Ltd. · 2016
  9. Descendant · 3 generations on · 0 of its ownK172925 Contact Lens Case, Model: A-1, B-1P L Overseas Limited · 2017
  10. Descendant · cites it directly · 0 of its ownK171539 Contact Lens CaseE-Link Plastic & Metal Industrial Co.,Ltd · 2017
  11. Descendant · cites it directly · 0 of its ownK171163 Contact Lens Case Round GlassesFiftytwoways, Ltd. · 2017

Most influential descendants

Showing 5 of 5 · See all
  • K142717Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye…Ni Hau Industrial Co., Ltd. · 2015 · cites it directly2descendants
  • K162869Contact Lens CaseNingbo Yinzhou Zonghai Artware Co., Ltd. · 2016 · 2 generations on1descendant
  • K172925Contact Lens Case, Model: A-1, B-1P L Overseas Limited · 2017 · 3 generations on0descendants
  • K171539Contact Lens CaseE-Link Plastic & Metal Industrial Co.,Ltd · 2017 · cites it directly0descendants
  • K171163Contact Lens Case Round GlassesFiftytwoways, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K920064Opti-Lens Contact Lens CaseRyder Intl. Corp.1992—
−4K042578I-Promotions Contact Lens CaseI-Promotions, Inc.2005—
−3K071081Contact Lens CaseNingbo Kaida Rubber and Plastic Technology Co., LT2007—
−2K093377Polaris Contact Lens CaseReliance Design & Manufacturing Corp.2010—
−1K120904Polaris Dial-a-Date Contact Lens CaseReliance Design & Manufacture Corp.2012—
0 (this device)K130930Owl Contact Lens Cases, Dog Contact Lens CasesNingbo Lishunda Electronics Co., Ltd.2014—
+1K142717Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case…Ni Hau Industrial Co., Ltd.2015—
+2K162869Contact Lens CaseNingbo Yinzhou Zonghai Artware Co., Ltd.2016—
+3K172925Contact Lens Case, Model: A-1, B-1P L Overseas Limited2017—
+1K171539Contact Lens CaseE-Link Plastic & Metal Industrial Co.,Ltd2017—
+1K171163Contact Lens Case Round GlassesFiftytwoways, Ltd.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201730
FIG. 1 — Lineage of K130930, 1992–2017Source: 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), 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. #1 K240095 CAREUS Contact Lens Case (Model 1, Model 2…score 15.3 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K120904Polaris Dial-a-Date Contact Lens Case
Summary page 1
…tion: 2 Regulation Number: 21 CFR 886.5928 Panel: General Ophthalmic Product Code: LRX Predicate Device Information: (1) K 120904, "The Polaris Dial-a-Date Contact Lens Case", manufactured by "Reliance Design & Manufacture Corp. " in Tainan, Taiwan D…
Reliance Design & Manufacture Corp.2012—

Also cleared against K120904: 1 other device →

What descends from it? (5)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K142717Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye…Ni Hau Industrial Co., Ltd.20152
K171539Contact Lens CaseE-Link Plastic & Metal Industrial Co.,Ltd20170
K171163Contact Lens Case Round GlassesFiftytwoways, Ltd.20170

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 22 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K142717 (Ni Hau Industrial Co., Ltd., 2015) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K120904.

How does its category compare?

All LRX devices

LRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

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—

What is it indicated for?

The "OWL Contact Lens Case" and "DOG Contact Lens Cases" are a device intended for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Used for storage during chemical disinfection only. Not for use during heat disinfection.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K130930: Owl Contact Lens Cases, Dog Contact Lens Cases.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130930

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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