510(k) · Cleared
ClearedRenu Multiplus Multi-Purpose Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · LPN Accessories, Soft Lens Products
Cleared on Mar 10, 1998 after an 82-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Mar 10, 1998
- Review
- 82 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK974723 Renu Multiplus Multi-Purpose SolutionBausch & Lomb, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK983780 Multi-Purpose Disinfecting Solution ID 90746Alcon Laboratories · 1998
- Descendant · cites it directly · 0 of its ownK102860 Alcon Multi-Pirpose Disinfecting SolutionAlcon Research, Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK021143 Opti-Free Express Multi-Purpose Disinfecting SolutionAlcon Universal, Ltd. · 2002 · Recalled
- Descendant · cites it directly · 0 of its ownK983973 Opti-One Multi-Purpose SolutionAlcon Laboratories · 1998
- Descendant · cites it directly · 0 of its ownK981574 Opti-Free Express Multi-Purpose SolutionAlcon · 1998
Most influential descendants
Showing 5 of 5 · See all- K983780Multi-Purpose Disinfecting Solution ID 90746Alcon Laboratories · 1998 · cites it directly1descendant
- K102860Alcon Multi-Pirpose Disinfecting SolutionAlcon Research, Ltd. · 2011 · cites it directly0descendants
- K021143Opti-Free Express Multi-Purpose Disinfecting SolutionAlcon Universal, Ltd. · 2002 · 2 generations on0descendants
- K983973Opti-One Multi-Purpose SolutionAlcon Laboratories · 1998 · cites it directly0descendants
- K981574Opti-Free Express Multi-Purpose SolutionAlcon · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974723 | Renu Multiplus Multi-Purpose Solution | Bausch & Lomb, Inc. | 1998 | — |
| +1 | K983780 | Multi-Purpose Disinfecting Solution ID 90746 | Alcon Laboratories | 1998 | — |
| +1 | K102860 | Alcon Multi-Pirpose Disinfecting Solution | Alcon Research, Ltd. | 2011 | — |
| +2 | K021143 | Opti-Free Express Multi-Purpose Disinfecting Solution | Alcon Universal, Ltd. | 2002 | 1 |
| +1 | K983973 | Opti-One Multi-Purpose Solution | Alcon Laboratories | 1998 | — |
| +1 | K981574 | Opti-Free Express Multi-Purpose Solution | Alcon | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 2002 | 1 | 0 |
| 2011 | 1 | 0 |
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 K253795 MeniSept 3% Hydrogen Peroxide Cleaning &…score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Bausch & Lomb ReNu Multi-Purpose Solution Named without a submission number | |
| * | — | Bausch & Lomb ReNu 1 Step Enzymatic Cleaner Named without a submission number |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K983780 (Alcon Laboratories, 1998) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPN
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LPN
167in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPN
40in 2025
MAUDE reports naming product code LPN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 175 | 2 | 1,151 |
| 2008 | 0 | — | 0 | 153 |
| 2009 | 1 | — | 2 | 121 |
| 2010 | 2 | — | 2 | 241 |
| 2011 | 3 | 222 | 1 | 273 |
| 2012 | 2 | — | 0 | 268 |
| 2013 | 2 | — | 0 | 84 |
| 2014 | 0 | — | 0 | 105 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 3 | 59 | 1 | 498 |
| 2017 | 1 | — | 0 | 2,666 |
| 2018 | 0 | — | 0 | 95 |
| 2019 | 2 | — | 0 | 60 |
| 2020 | 3 | 167 | 1 | 82 |
| 2021 | 2 | — | 0 | 51 |
| 2022 | 2 | — | 0 | 62 |
| 2023 | 0 | — | 0 | 84 |
| 2024 | 0 | — | 0 | 76 |
| 2025 | 0 | — | 0 | 40 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution is indicated for use in the 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.
https://510kreport.com/device/K974723 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974723: Renu Multiplus Multi-Purpose Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974723
Report an extraction error
Are you the manufacturer?
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