510(k) Report

510(k) · Cleared

Cleared

AC Lens Branded Contact Lens Case

K120969510(k) TraditionalCleared Jul 11, 2012103-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

Arlington Contact Lens Services,Inc. · LRX Case, Contact Lens

Cleared on Jul 11, 2012 as substantially equivalent to K071081 (Ningbo Kaida Rubber and Plastic Technology Co., LT, 2007) after a 103-day review. Its family tree reaches back 3 generations to 1992. 2 later devices descend from it.

Decided
Jul 11, 2012
Review
103 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. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2014: 1 descendant cleared2017: 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 descendant2 generations 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 deviceK120969 AC Lens Branded Contact Lens CaseArlington Contact Lens Services,Inc. · 2012
  5. Descendant · cites it directly · 1 of its ownK140488 Contact Lens CaseMaca Plastics, Inc. · 2014
  6. Descendant · 2 generations on · 0 of its ownK172925 Contact Lens Case, Model: A-1, B-1P L Overseas Limited · 2017

Most influential descendants

Showing 2 of 2 · See all
  • K140488Contact Lens CaseMaca Plastics, Inc. · 2014 · cites it directly1descendant
  • K172925Contact Lens Case, Model: A-1, B-1P L Overseas Limited · 2017 · 2 generations on0descendants
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)K120969AC Lens Branded Contact Lens CaseArlington Contact Lens Services,Inc.2012—
+1K140488Contact Lens CaseMaca Plastics, Inc.2014—
+2K172925Contact Lens Case, Model: A-1, B-1P L Overseas Limited2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201710
FIG. 1 — Lineage of K120969, 1992–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 15.4 · 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
*K071081Contact Lens Case
Summary page 1
…- -FKNme-N me Ningbo Kaida Rubber and Plastic Contact Lens Case K071081 Technolog Co., Ltd DEVICE DESCRIPTION 807.92(a)(4) The AC Branded Contact Lens Cas…
Ningbo Kaida Rubber and Plastic Technology Co., LT2007—

Also cleared against K071081: 3 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K140488Contact Lens CaseMaca Plastics, Inc.20141

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 4 companies; a new generation was cleared every 5.2 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K140488 (Maca Plastics, Inc., 2014) has gone furthest, with 1 descendant 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. 2012, 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 applicant contact case is to be used by the contact lens wearer or practitioner for storing soft, rigid gas permeable or hard contact lenses while not in use. Intended for chemical disinfection only. Not designed for heat disinfecting system.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K120969: AC Lens Branded Contact Lens Case.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120969

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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