510(k) · Cleared
ClearedOne Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Menicon Co, Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on May 16, 2018 as substantially equivalent to K080632 (Clearlab SG Pte, Ltd., 2008) and 2 other predicates after a 48-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- May 16, 2018
- Review
- 48 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K962804 (1996). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
- 5 generations backK980634 Frequency UV (Etafilcon a) Hydrophilic Contact Lens for Daily Wear…Aspect Vision Care, Ltd. · 1998
- 4 generations backK030167 Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility…Clearlab Pte, Ltd. · 2003
- 3 generations backK052290 Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd. · 2006
- 2 generations backK080632 CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact LensClearlab SG Pte, Ltd. · 2008
- 1 generation backK102895 One Day Flat PackMenicon Co, Ltd. · 2011
- This deviceK180819 One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact LensMenicon Co, Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | 1996 | — |
| −5 | K980634 | Frequency UV (Etafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear and… | Aspect Vision Care, Ltd. | 1998 | — |
| −4 | K030167 | Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility Tint, with UV… | Clearlab Pte, Ltd. | 2003 | — |
| −3 | K052290 | Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact Lens | Clearlab Pte, Ltd. | 2006 | — |
| −2 | K080632 | CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact Lens | Clearlab SG Pte, Ltd. | 2008 | — |
| −1 | K102895 | One Day Flat Pack | Menicon Co, Ltd. | 2011 | — |
| 0 (this device) | K180819 | One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens | Menicon Co, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 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 LPL? 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 LPL device
- #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 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 |
|---|---|---|---|
| * | K080632 | CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact LensSummary page 4…Flat Pack (hioxifilcon A) Multifocal Daily Disposable Soft Contact Lens 3. Predicate Devices Menicon claims substantial equivalence to K080632 Clear 1-Day (hioxifilcon A) Soft Contact Lens, K102895 One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens… | 2008 |
| * | K102895 | One Day Flat PackSummary page 4…Daily Disposable Soft Contact Lens 3. Predicate Devices Menicon claims substantial equivalence to K080632 Clear 1-Day (hioxifilcon A) Soft Contact Lens, K102895 One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens and K161739 Aquamax (etafilcon A) Soft Contact Lens. 4.… | 2011 |
| * | K161739 | Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft…Summary page 4…substantial equivalence to K080632 Clear 1-Day (hioxifilcon A) Soft Contact Lens, K102895 One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens and K161739 Aquamax (etafilcon A) Soft Contact Lens. 4. Description of Device The One Day Flat Pack (hioxifilcon A) Daily Disposable Sof… | 2016 |
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 22 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- None of the 16 ancestors has a recall.
- 2 other devices also cite its predicate K080632.
How does its category compare?
All LPL devicesLPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LPL
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPL
202in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPL
216in 2025
MAUDE reports naming product code LPL, 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 | 3 | 281 | 1 | 280 |
| 2008 | 10 | 104 | 0 | 214 |
| 2009 | 6 | 260 | 1 | 137 |
| 2010 | 9 | 244 | 0 | 222 |
| 2011 | 12 | 170 | 5 | 377 |
| 2012 | 12 | 131 | 1 | 250 |
| 2013 | 17 | 135 | 0 | 151 |
| 2014 | 15 | 102 | 1 | 179 |
| 2015 | 12 | 120 | 1 | 161 |
| 2016 | 21 | 112 | 0 | 193 |
| 2017 | 9 | 98 | 11 | 280 |
| 2018 | 21 | 56 | 0 | 257 |
| 2019 | 11 | 115 | 0 | 205 |
| 2020 | 10 | 158 | 1 | 117 |
| 2021 | 8 | 88 | 0 | 110 |
| 2022 | 9 | 212 | 1 | 126 |
| 2023 | 10 | 167 | 0 | 178 |
| 2024 | 12 | 128 | 0 | 297 |
| 2025 | 12 | 202 | 1 | 216 |
| 2026 | 10 | 90 | 1 | — |
What is it indicated for?
One Day Flat Pack (hioxifilcon A) Spherical Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes who may have 1.00 diopter (D) or less of astigmatism that does not interfere with visual acuity. One Day Flat Pack (hioxifilcon A) Multifocal Lens is indicated for daily wear for the optical correction of refractive ametropia (myopia…
Read the full statement (160 words)
One Day Flat Pack (hioxifilcon A) Spherical Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes who may have 1.00 diopter (D) or less of astigmatism that does not interfere with visual acuity.
One Day Flat Pack (hioxifilcon A) Multifocal Lens is indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in aphakic and non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have 1.00 D or less of astigmatism that does not interfere with visual acuity.
One Day Flat Pack (hioxifilcon A) Spherical and Multifocal Lenses are intended to be worn once and then discarded at the end of each wearing period on a daily basis. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
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/K180819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180819: One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180819
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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