510(k) · Cleared
ClearedOTE MPS 045 Multi-purpose Lens Care Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ote North America, LLC · LPN Accessories, Soft Lens Products
Cleared on May 26, 2021 as substantially equivalent to K083757 (Bausch & Lomb, Inc., 2009) after a 138-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- May 26, 2021
- Review
- 138 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K021635 (2002). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK021635 Karats Multipurpose SolutionCiba Vision Corporation · 2002
- 2 generations backK033608 Aquify Multi-Purpose SolutionCiba Vision Corporation · 2004
- 1 generation backK083757 BPZ02 Multipurpose SolutionBausch & Lomb, Inc. · 2009 · Recalled
- This deviceK210051 OTE MPS 045 Multi-purpose Lens Care SolutionOte North America, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K021635 | Karats Multipurpose Solution | Ciba Vision Corporation | 2002 | — |
| −2 | K033608 | Aquify Multi-Purpose Solution | Ciba Vision Corporation | 2004 | — |
| −1 | K083757 | BPZ02 Multipurpose Solution | Bausch & Lomb, Inc. | 2009 | 2 |
| 0 (this device) | K210051 | OTE MPS 045 Multi-purpose Lens Care Solution | Ote North America, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K083757 | BPZ02 Multipurpose SolutionSummary page 4…OTE MPS 045 Multi-Purpose Lens Care Solution Product code: LPN 3. Predicate Device OTE North America claims substantial equivalence to K083757 Bausch & Lomb® BPZ02, commercially distributed as Biotrue® Multi-Purpose Solution. 4. Description of Device OTE MPS… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K083757.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
OTE MPS 045 Multi-Purpose Lens Care Solution is indicated for daily cleaning, chemical (not heat) disinfection, conditioning, rinsing and storage of hydrogel and silicone hydrogel 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/K210051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210051: OTE MPS 045 Multi-purpose Lens Care Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210051
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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