510(k) · Cleared
ClearedREFRESH RELIEVA For CONTACTS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allergan, Inc. · LPN Accessories, Soft Lens Products
Cleared on Aug 8, 2019 as substantially equivalent to K992028 (Allergan, Inc., 1999) and 1 other predicate after a 146-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Aug 8, 2019
- Review
- 146 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to P910075/
- Root · 3 generations backP910075/
S007 Complete Brand Lubricating and Rewetting DropsAdvanced Medical Optics, Inc. · 1996 - 2 generations backK992028 Refresh Contacts Lubricating and Rewetting DropsAllergan, Inc. · 1999 · Recalled
- 1 generation backK083812 Refresh Optive Lens Comfort Rewetting DropsAllergan, Inc. · 2009
- This deviceK190674 REFRESH RELIEVA For CONTACTSAllergan, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P910075/ | Complete Brand Lubricating and Rewetting Drops | Advanced Medical Optics, Inc. | 1996 | — |
| −2 | K992028 | Refresh Contacts Lubricating and Rewetting Drops | Allergan, Inc. | 1999 | 1 |
| −1 | K083812 | Refresh Optive Lens Comfort Rewetting Drops | Allergan, Inc. | 2009 | — |
| 0 (this device) | K190674 | REFRESH RELIEVA For CONTACTS | Allergan, Inc. | 2019 | — |
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 DropsSummary page 4…Class II Product Code: LPN and MRC Predicate Device The predicate devices are: • REFRESH® Contacts Lubricating and Rewetting Drops (K992028) • REFRESH OPTIVE CONTACTS Lubricating and Rewetting Drops (K083812) Description of Device REFRESH® RELIEVA™ FOR CONTACTS i… | 1999 |
| * | K083812 | Refresh Optive Lens Comfort Rewetting DropsSummary page 4…edicate Device The predicate devices are: • REFRESH® Contacts Lubricating and Rewetting Drops (K992028) • REFRESH OPTIVE CONTACTS Lubricating and Rewetting Drops (K083812) Description of Device REFRESH® RELIEVA™ FOR CONTACTS is a sterile, buffered, isotonic, preserved solution. This aqueous formu… | 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 23 years and passes through 2 companies; a new generation was cleared every 9.8 years on median.
- 1 of the 3 ancestors has 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. 2019, 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?
REFRESH® RELIEVA™ FOR CONTACTS is indicated to lubricate and rewet soft and rigid gas permeable contact lenses, to help relieve dryness, discomfort and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to the application on the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190674 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190674: REFRESH RELIEVA For CONTACTS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190674
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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