510(k) Report

510(k) · Cleared

Cleared

I-Promotions Contact Lens Case

K042578510(k) TraditionalCleared Jan 25, 2005125-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

I-Promotions, Inc. · LRX Case, Contact Lens

Cleared on Jan 25, 2005 as substantially equivalent to K030987 (Pelican Products, 2003) and 1 other predicate after a 125-day review. Its family tree reaches back 1 generation to 1992. 23 later devices descend from it.

Decided
Jan 25, 2005
Review
125 days
Class
Class II
Product code
LRX
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K920064 (1992). 2 ancestors in all. 23 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2007: 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 clearedK920064 · Opti-Lens Contact Lens Case · Ryder Intl. Corp. · 19921990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 6 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 5 descendants6 generations forward: 1 descendant K920064 · Opti-Lens Contact Lens Case · Ryder Intl. Corp. · 19920+5
  1. Root · 1 generation backK920064 Opti-Lens Contact Lens CaseRyder Intl. Corp. · 1992
  2. This deviceK042578 I-Promotions Contact Lens CaseI-Promotions, Inc. · 2005
  3. Descendant · cites it directly · 17 of its ownK071081 Contact Lens CaseNingbo Kaida Rubber and Plastic Technology Co., LT · 2007
  4. Descendant · 2 generations on · 11 of its ownK093377 Polaris Contact Lens CaseReliance Design & Manufacturing Corp. · 2010
  5. Descendant · 3 generations on · 9 of its ownK120904 Polaris Dial-a-Date Contact Lens CaseReliance Design & Manufacture Corp. · 2012
  6. Descendant · 4 generations on · 5 of its ownK130930 Owl Contact Lens Cases, Dog Contact Lens CasesNingbo Lishunda Electronics Co., Ltd. · 2014
  7. Descendant · 4 generations on · 2 of its ownK240095 CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model…Shanghai Care US Medical Product Co., Ltd. · 2024

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2007: 12010: 12011: 22012: 32013: 32014: 32015: 12016: 22017: 32023: 12024: 12025: 12026: 1
2007high 3 (2012) · low 0 (2008)2026

Most influential descendants

Showing 5 of 23 · See all
  • K071081Contact Lens CaseNingbo Kaida Rubber and Plastic Technology Co., LT · 2007 · cites it directly17descendants
  • K093377Polaris Contact Lens CaseReliance Design & Manufacturing Corp. · 2010 · 2 generations on11descendants
  • K120904Polaris Dial-a-Date Contact Lens CaseReliance Design & Manufacture Corp. · 2012 · 3 generations on9descendants
  • K130930Owl Contact Lens Cases, Dog Contact Lens CasesNingbo Lishunda Electronics Co., Ltd. · 2014 · 4 generations on5descendants
  • K240095CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)Shanghai Care US Medical Product Co., Ltd. · 2024 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K920064Opti-Lens Contact Lens CaseRyder Intl. Corp.1992—
0 (this device)K042578I-Promotions Contact Lens CaseI-Promotions, Inc.2005—
+1K071081Contact Lens CaseNingbo Kaida Rubber and Plastic Technology Co., LT2007—
+2K093377Polaris Contact Lens CaseReliance Design & Manufacturing Corp.2010—
+3K120904Polaris Dial-a-Date Contact Lens CaseReliance Design & Manufacture Corp.2012—
+4K130930Owl Contact Lens Cases, Dog Contact Lens CasesNingbo Lishunda Electronics Co., Ltd.2014—
+4K240095CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)Shanghai Care US Medical Product Co., Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201010
201120
201230
201330
201430
201510
201620
201730
202310
202410
202510
202610
FIG. 1 — Lineage of K042578, 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), 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? (2)

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
*K030987Contact Lens Storage Case
Summary page 1
…rlotte Slankard President i-Promotion, Inc. Predicate Device: Pelican Contact Lens Case K030987 And OptiLensTM Contact Lens Case K920064 Device Description And Intended Use:…
Pelican Products2003—
*K920064Opti-Lens Contact Lens Case
Summary page 1
…i-Promotion, Inc. Predicate Device: Pelican Contact Lens Case K030987 And OptiLensTM Contact Lens Case K920064 Device Description And Intended Use: The i[Promotions Contact Lens Case consists of a lens case…
Ryder Intl. Corp.1992—

Also cleared against K030987: 2 other devices →

What descends from it? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K071081Contact Lens CaseNingbo Kaida Rubber and Plastic Technology Co., LT200717
K121030Sacks Holdings Inc.'S Contact Lens Storage CaseSacks Holdings, Inc.20121
K112832Eye Care Cure Contact Lens CaseEye Care and Cure20111
K122700Prosben Contact Lens Cases Model CA66-02, CA66-03WB, CA66-04T SeriesProsben, Inc.20130
K111856Soft Grip Contact Lens Case, Deluxe Contact Lens Case, Econo-Mate Contact Lens CaseApothecary Products, Inc.20110

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K071081 (Ningbo Kaida Rubber and Plastic Technology Co., LT, 2007) has gone furthest, with 17 descendants of its own.
  • 2 other devices also cite its predicate K030987.

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—

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.

Also cleared against K030987

2 other devices cite the same predicate.

  • K112832Eye Care Cure Contact Lens CaseEye Care and Cure · 2011
  • K040914Polyvial/Polypak, Contact Lens Case and Storage System Container for OphthalmicsExero Products, Inc. · 2004

Recent decisions in LRX

The LRX category page

  • K252175LANDR Contact LENS CaseFourth Axis, LLC · 2026
  • K250495Mini VP1 (PL67_F); Mini VP1 (PL61_F)Avizor S.A. · 2025
  • K240095CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)Shanghai Care US Medical Product Co., Ltd. · 2024
  • K231123Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack…Phoenix Innovative Healthcare Manufacturers Pvt., Ltd. · 2023
  • K173538Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc. · 2017

https://510kreport.com/device/K042578 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042578: I-Promotions 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/K042578

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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