510(k) · Cleared
Recalled · 2005Aquify Lens Comfort Drops
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciba Vision Corporation · MRC Products, Contact Lens Care, Rigid Gas Permeable
Cleared on Apr 3, 2002 after a 190-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 3, 2002
- Review
- 190 days
- Class
- Class II
- Product code
- MRC
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK013204 Aquify Lens Comfort DropsCiba Vision Corporation · 2002
- Descendant · cites it directly · 0 of its ownK032481 Theratears Contact Lens Comfort DropsAdvanced Vision Research, Inc. · 2003
Most influential descendants
Showing 1 of 1 · See all- K032481Theratears Contact Lens Comfort DropsAdvanced Vision Research, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013204 | Aquify Lens Comfort Drops | Ciba Vision Corporation | 2002 | — |
| +1 | K032481 | Theratears Contact Lens Comfort Drops | Advanced Vision Research, Inc. | 2003 | — |
Descendants 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 MRC? 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 MRC device
- #1 K251876 cleadew GP hydra onescore 10.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | ReNu Multiplus Lubricating and Rewetting Drops Named without a submission number | |
| * | — | Visine for Contacts Named without a submission number | |
| * | — | Hylashield CL Lubricating Eye Drops Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032481 | Theratears Contact Lens Comfort Drops | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 2, 2005 | Not classified | Z-0182-06 | Other | Lack of assurance of sterility at the time of manufacture. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K032481 (Advanced Vision Research, Inc., 2003) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MRC devicesMRC Products, Contact Lens Care, Rigid Gas Permeable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MRC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRC
51in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRC
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRC
72in 2025
MAUDE reports naming product code MRC, 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 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 51 | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 3 |
| 2021 | 0 | — | 1 | 1 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 72 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Use AQuify Lens Comfort Drops to moisten, cushion, refresh, and provide temporary relief from dryness and irritation associated with contact lens wearing.
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/K013204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013204: Aquify Lens Comfort Drops.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013204
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026