510(k) · Cleared
ClearedTheratears Contact Lens Comfort Drops
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Vision Research, Inc. · LPN Accessories, Soft Lens Products
Cleared on Nov 4, 2003 as substantially equivalent to K992028 (Allergan, Inc., 1999) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Nov 4, 2003
- Review
- 84 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to P910075/
- Root · 2 generations backP910075/
S007 Complete Brand Lubricating and Rewetting DropsAdvanced Medical Optics, Inc. · 1996 - 1 generation backK992028 Refresh Contacts Lubricating and Rewetting DropsAllergan, Inc. · 1999 · Recalled
- This deviceK032481 Theratears Contact Lens Comfort DropsAdvanced Vision Research, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P910075/ | Complete Brand Lubricating and Rewetting Drops | Advanced Medical Optics, Inc. | 1996 | — |
| −1 | K992028 | Refresh Contacts Lubricating and Rewetting Drops | Allergan, Inc. | 1999 | 1 |
| 0 (this device) | K032481 | Theratears Contact Lens Comfort Drops | Advanced Vision Research, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K992028 | Refresh Contacts Lubricating and Rewetting Drops Our reading of the summary gave K992928, FDA’s number for CD Horizon Spinal System (Sofamor Danek USA,Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Allergan Refresh Contacts”. | 1999 |
| * | K013204 | Aquify Lens Comfort DropsSummary page 1…roducts (886.5928) Rigid gas permeable contact lens care products (886.5918) Predicate Device: Allergan Refresh ContactsTM(K992928) AQuify lens Comfort Drops (K013204) Device Description: TheraTears@brand Contact Lens Comfort Drops contains carmellose sodium in purified water as a lubric… | 2002 |
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 7 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K992028.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
TheraTears Contact Lens Comfort Drops is indicated
to lubricate and rewet soft (hydrophilic) and RGP* (rigid gas permeable) contact lenses,
to help relieve dryness, discomfort and irn'tation that may be associated with lens wear and,
to cushion lenses and ease insertion.
RGP lenses include silicone acrylate and fluoro silicone acrylate rigid gas permeable lenses. Consult with your eye care practitioner to identify your RGP material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032481: Theratears Contact 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/K032481
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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