510(k) · Cleared
ClearedContaclair Multi-Purpose Contact Lens Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Strieter Clinical Research Laboratories, Inc. · LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
Cleared on Feb 22, 2000 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 22, 2000
- Review
- 88 days
- Class
- Class II
- Product code
- LYL
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 K211361 3N Contact Lenses Adjunct Cleanerscore 3.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All LYL devicesLYL 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
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYL
4in 2025
MAUDE reports naming product code LYL, 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 | 0 | — | 1 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 8 | 9 |
| 2011 | 0 | — | 1 | 10 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 1 | 5 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 1 | 5 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ContaClair® Multi-Purpose Solution is indicated for use in cleaning, rinsing, disinfecting, protein removal and storing daily and extended wear soft (hydrophilic) and RGP (rigid gas permeable) contact lenses as recommended by your practitioner. ContaClair is indicated for use in chemical (not heat) lens care regimen.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994021: Contaclair Multi-Purpose 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/K994021
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026