510(k) · Cleared
ClearedAltaire MPS#1 Multipurpose Contact Lens Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Altaire Pharmaceuticals, Inc. · LPN Accessories, Soft Lens Products
Cleared on Apr 25, 2007 as substantially equivalent to K991403 (Ciba Vision Corporation, 1999) and 1 other predicate after a 258-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Apr 25, 2007
- Review
- 258 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K991403 (1999). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK991403 Solo-Care Brand Multi-Purpose SolutionCiba Vision Corporation · 1999
- This deviceK062332 Altaire MPS#1 Multipurpose Contact Lens SolutionAltaire Pharmaceuticals, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991403 | Solo-Care Brand Multi-Purpose Solution | Ciba Vision Corporation | 1999 | — |
| 0 (this device) | K062332 | Altaire MPS#1 Multipurpose Contact Lens Solution | Altaire Pharmaceuticals, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K991403 | Solo-Care Brand Multi-Purpose SolutionSummary page 1…ropriety Name Altaire MPS#1 Multipurpose Contact Lens Solution 3. Predicate Device SOLO-care, and SOLO-Care Plus Multipurpose Solution; K991403 & K012731. This product was selected because the formulation and indications for use are identical to the devic… | 1999 |
| * | K012731 | Solo-Care Plus Multipurpose SolutionSummary page 1…ame Altaire MPS#1 Multipurpose Contact Lens Solution 3. Predicate Device SOLO-care, and SOLO-Care Plus Multipurpose Solution; K991403 & K012731. This product was selected because the formulation and indications for use are identical to the device proposed… | 2001 |
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?
- None of the 2 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. 2007, 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?
The Altaire MPS#1 Multipurpose Contact Lens Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, daily protein removal, and storing of soft (hydrophilic) contact lenses, rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062332: Altaire MPS#1 Multipurpose Contact Lens Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062332
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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