510(k) Report

510(k) · Cleared

Cleared

Standard Contact Lens Case; Flip N Slide Contact Lens Case

K130753510(k) TraditionalCleared Jun 13, 201386-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

Watchdog Group, LC · LRX Case, Contact Lens

Cleared on Jun 13, 2013 as substantially equivalent to K071081 (Ningbo Kaida Rubber and Plastic Technology Co., LT, 2007) after an 86-day review. Its family tree reaches back 3 generations to 1992. 1 later device descends from it.

Decided
Jun 13, 2013
Review
86 days
Class
Class II
Product code
LRX
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K920064 (1992). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2014: 1 descendant clearedK920064 · Opti-Lens Contact Lens Case · Ryder Intl. Corp. · 1992K042578 · I-Promotions Contact Lens Case · I-Promotions, Inc. · 2005K071081 · Contact Lens Case · Ningbo Kaida Rubber and Plastic Technology Co., LT · 20071990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 1 descendant K071081 · Contact Lens Case · Ningbo Kaida Rubber and Plastic Technology Co., LT · 2007K042578 · I-Promotions Contact Lens Case · I-Promotions, Inc. · 2005K920064 · Opti-Lens Contact Lens Case · Ryder Intl. Corp. · 19920
  1. Root · 3 generations backK920064 Opti-Lens Contact Lens CaseRyder Intl. Corp. · 1992
  2. 2 generations backK042578 I-Promotions Contact Lens CaseI-Promotions, Inc. · 2005
  3. 1 generation backK071081 Contact Lens CaseNingbo Kaida Rubber and Plastic Technology Co., LT · 2007
  4. This deviceK130753 Standard Contact Lens Case; Flip N Slide Contact Lens CaseWatchdog Group, LC · 2013
  5. Descendant · cites it directly · 0 of its ownK131783 Polaroid ContactspodViopti, Ltd. · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K131783Polaroid ContactspodViopti, Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K920064Opti-Lens Contact Lens CaseRyder Intl. Corp.1992—
−2K042578I-Promotions Contact Lens CaseI-Promotions, Inc.2005—
−1K071081Contact Lens CaseNingbo Kaida Rubber and Plastic Technology Co., LT2007—
0 (this device)K130753Standard Contact Lens Case; Flip N Slide Contact Lens CaseWatchdog Group, LC2013—
+1K131783Polaroid ContactspodViopti, Ltd.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K130753, 1992–2014Source: 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
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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
*K071081Contact Lens Case
Summary page 1
…; Soft (hydrophilic) contact lens care products, Class 11 Product Code: LRX Predicate Device: Contact lens cases by Ningbo Kaida Rubber & Plastic Technology Co., LT (k071081) Device Description: The contact lens cases are designed for storage of contact lenses. The Color Case Contact Lens Case has 2…
Ningbo Kaida Rubber and Plastic Technology Co., LT2007—

Also cleared against K071081: 3 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K131783Polaroid ContactspodViopti, Ltd.20140

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 21 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K131783 (Viopti, Ltd., 2014) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K071081.

How does its category compare?

All LRX devices

LRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?

Intended for the storage of soft (hydrophilic), rigid gas permeable (RGP), or hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only.

Do not use during heat disinfection.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K130753: Standard Contact Lens Case; Flip N Slide Contact Lens Case.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130753

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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