510(k) Report

510(k) · Cleared

Recalled · 2011

Renut Multiplus Mullti-Purpose Solution

K020802510(k) TraditionalCleared May 31, 200280-day reviewClass II21 CFR 886.5928Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bausch & Lomb, Incorporated · LYL Accessories, Solution, Ultrasonic Cleaners For Lenses

Cleared on May 31, 2002 after an 80-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled 2 times.

Decided
May 31, 2002
Review
80 days
Class
Class II
Product code
LYL
Recalls
2
Predicates
0

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

Descendants, by year cleared 2015: 1 descendant cleared2020: 1 descendant cleared2019: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK020802 Renut Multiplus Mullti-Purpose SolutionBausch & Lomb, Incorporated · 2002
  2. Descendant · cites it directly · 3 of its ownK142284 Clear Care Plus Cleaning & Disinfectiong Solution with HydraglydeAlcon Laboratories, Inc. · 2015 · Recalled
  3. Descendant · 2 generations on · 1 of its ownK191872 Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionMenicon Co, Ltd. · 2020
  4. Descendant · 3 generations on · 0 of its ownK253795 MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd. · 2026
  5. Descendant · 2 generations on · 0 of its ownK191795 AOCup Lens Case with AODiscAlcon Laboratories, Inc. · 2019

Most influential descendants

Showing 4 of 4 · See all
  • K142284Clear Care Plus Cleaning & Disinfectiong Solution with HydraglydeAlcon Laboratories, Inc. · 2015 · cites it directly3descendants
  • K191872Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionMenicon Co, Ltd. · 2020 · 2 generations on1descendant
  • K253795MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd. · 2026 · 3 generations on0descendants
  • K191795AOCup Lens Case with AODiscAlcon Laboratories, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K020802Renut Multiplus Mullti-Purpose SolutionBausch & Lomb, Incorporated2002—
+1K142284Clear Care Plus Cleaning & Disinfectiong Solution with HydraglydeAlcon Laboratories, Inc.20151
+2K191872Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionMenicon Co, Ltd.2020—
+3K253795MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd.2026—
+2K191795AOCup Lens Case with AODiscAlcon Laboratories, Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201910
202010
202610
FIG. 1 — Lineage of K020802, 2002–2026Source: 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 LYL? 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 LYL device

  1. #1 K211361 3N Contact Lenses Adjunct Cleanerscore 3.6 · 4 generations · no Class I recall
  2. #2 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
*—Alcon OPTI-FREE EXPRESS No Rub
Named without a submission number
—

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K142284Clear Care Plus Cleaning & Disinfectiong Solution with HydraglydeAlcon Laboratories, Inc.20153

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 30, 2011Not classifiedZ-3042-2011PackagingMuti-purpose solution bottles, lot GC1107 were packaged in a carton that was marked with an incorrect lot code and expiration date.
Mar 5, 2007Not classifiedZ-0715-2007OtherA higher than expected amount of trace iron in some bottles of finished product that over time affects the product's stability and color.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K142284 (Alcon Laboratories, Inc., 2015) has gone furthest, with 3 descendants of its own.

How does its category compare?

All LYL devices

LYL Accessories, Solution, Ultrasonic Cleaners For Lenses: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYL

1in 2022

2009: 12021: 12022: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYL

Too few LYL 510(k)s in any year since 2007 to give a median.

Recalls per year · LYL

1in 2023

2007: 12010: 82011: 12014: 12023: 1
2007high 8 (2010) · low 0 (2008)2026

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

Adverse event reports per year · LYL

4in 2025

2007: 12009: 12010: 92011: 102012: 72013: 62014: 52015: 22016: 62017: 32018: 52019: 12021: 22022: 32023: 52024: 52025: 4
2007high 10 (2011) · low 0 (2008)2025

MAUDE reports naming product code LYL, 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
20070—11
20080—00
20091—01
20100—89
20110—110
20120—07
20130—06
20140—15
20150—02
20160—06
20170—03
20180—05
20190—01
20200—00
20211—02
20221—03
20230—15
20240—05
20250—04
20260—0—

What is it indicated for?

ReNu MultiPlus Multi-Purpose Solution is indicated for use in daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

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. “K020802: Renut Multiplus Mullti-Purpose Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020802

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