510(k) Report

510(k) · Cleared

Cleared

Complete Brand Multi-Purpose Solution

K013479510(k) TraditionalCleared Feb 11, 2002115-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

Allergan, Inc. · LPN Accessories, Soft Lens Products

Cleared on Feb 11, 2002 after a 115-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided
Feb 11, 2002
Review
115 days
Class
Class II
Product code
LPN
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2021: 1 descendant clearedReference device: K003252 · Complete Brand Multi-Purpose Solution · Allergan, Inc. · 2001200020052010201520202025
  1. This deviceK013479 Complete Brand Multi-Purpose SolutionAllergan, Inc. · 2002
  2. Descendant · cites it directly · 1 of its ownK014202 Complete Brand Multi-Purpose SolutionAllergan, Inc. · 2002 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK202932 ABT12 multi-purpose solutionBausch & Lomb, Incorporated · 2021

Most influential descendants

Showing 2 of 2 · See all
  • K014202Complete Brand Multi-Purpose SolutionAllergan, Inc. · 2002 · cites it directly1descendant
  • K202932ABT12 multi-purpose solutionBausch & Lomb, Incorporated · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K013479Complete Brand Multi-Purpose SolutionAllergan, Inc.2002—
+1K014202Complete Brand Multi-Purpose SolutionAllergan, Inc.20022
+2K202932ABT12 multi-purpose solutionBausch & Lomb, Incorporated2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
202110
FIG. 1 — Lineage of K013479, 2002–2021Source: 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 LPN? 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 LPN device

  1. #1 K253795 MeniSept 3% Hydrogen Peroxide Cleaning &…score 12.7 · 4 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
*—COMPLETE® brand Multi-Purpose Solution
Named without a submission number
—
†K003252Complete Brand Multi-Purpose SolutionAllergan, Inc.2001—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K014202Complete Brand Multi-Purpose SolutionAllergan, Inc.20021

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, K014202 (Allergan, Inc., 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LPN devices

LPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPN

2in 2022

2007: 42009: 12010: 22011: 32012: 22013: 22015: 22016: 32017: 12019: 22020: 32021: 22022: 22026 (partial year): 1
2007high 4 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPN

167in 2020

2007: 175 days median2011: 222 days median2016: 59 days median2020: 167 days median
2007high 222 (2011) · low 59 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPN

1in 2020

2007: 22009: 22010: 22011: 12016: 12020: 1
2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPN

40in 2025

2007: 1,1512008: 1532009: 1212010: 2412011: 2732012: 2682013: 842014: 1052015: 1762016: 4982017: 2,6662018: 952019: 602020: 822021: 512022: 622023: 842024: 762025: 40
2007high 2,666 (2017) · low 40 (2025)2025

MAUDE reports naming product code LPN, 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
2007417521,151
20080—0153
20091—2121
20102—2241
201132221273
20122—0268
20132—084
20140—0105
20152—0176
20163591498
20171—02,666
20180—095
20192—060
20203167182
20212—051
20222—062
20230—084
20240—076
20250—040
20261—0—

What is it indicated for?

COMPLETE® brand Multi-Purpose Solution is indicated for the care of soft (hydrophilic) contact lenses. Use this product, as recommended by your eye care practitioner, to:

e Chemically (NOT HEAT) Disinfect

Clean

Rinse

Store

Remove Protein

Condition

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. “K013479: Complete Brand Multi-Purpose Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013479

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026