510(k) · Cleared
Recalled · Class II · 2016Bausch + Lomb Peroxiclear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Incorporated · LPN Accessories, Soft Lens Products
Cleared on Sep 9, 2013 as substantially equivalent to K112909 (Bausch & Lomb, Inc., 2012) after a 54-day review. Its family tree reaches back 2 generations to 2002. It has been recalled once.
- Decided
- Sep 9, 2013
- Review
- 54 days
- Class
- Class II
- Product code
- LPN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022687 (2002). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK022687 Aosept Clear Care Cleaning and Disinfecting SolutionCiba Vision Corporation · 2002
- 1 generation backK112909 OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting SoultionBausch & Lomb, Inc. · 2012
- This deviceK132216 Bausch + Lomb Peroxiclear 3% Hydrogen Peroxide Cleaning &…Bausch & Lomb, Incorporated · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022687 | Aosept Clear Care Cleaning and Disinfecting Solution | Ciba Vision Corporation | 2002 | — |
| −1 | K112909 | OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Soultion | Bausch & Lomb, Inc. | 2012 | — |
| 0 (this device) | K132216 | Bausch + Lomb Peroxiclear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution | Bausch & Lomb, Incorporated | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112909 | OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting SoultionSummary page 2…rigid gas permeable contact enses, as recommended by your eye care practitioner. The intended use above is identical to what was cleared in the original 510(k) (K 112909). 3 Technological Characteristics: The table below shows a side-by-side comparison of the technologi… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 19, 2016 | Class II | Z-0651-2017 | Under Investigation by firm | Product was found to contain excess residual levels of hydrogen peroxide. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 PeroxiClearTM 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is indicated for the daily cleaning, removal of protein deposits, disinfection, and storage of soft (hydrophilic) contact lenses (including silicone hydrogel) and rigid gas permeable contact lenses, as recommended by your eye care practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132216 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132216: Bausch + Lomb Peroxiclear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132216
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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