510(k) · Cleared
ClearedOne Day Flat Pack
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 Apr 28, 2011 as substantially equivalent to K080632 (Clearlab SG Pte, Ltd., 2008) after a 210-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Apr 28, 2011
- Review
- 210 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K962804 (1996). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
- 4 generations backK980634 Frequency UV (Etafilcon a) Hydrophilic Contact Lens for Daily Wear…Aspect Vision Care, Ltd. · 1998
- 3 generations backK030167 Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility…Clearlab Pte, Ltd. · 2003
- 2 generations backK052290 Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd. · 2006
- 1 generation backK080632 CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact LensClearlab SG Pte, Ltd. · 2008
- This deviceK102895 One Day Flat PackMenicon Co, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK180819 One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact LensMenicon Co, Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K180819One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact LensMenicon Co, Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | 1996 | — |
| −4 | K980634 | Frequency UV (Etafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear and… | Aspect Vision Care, Ltd. | 1998 | — |
| −3 | K030167 | Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility Tint, with UV… | Clearlab Pte, Ltd. | 2003 | — |
| −2 | K052290 | Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact Lens | Clearlab Pte, Ltd. | 2006 | — |
| −1 | K080632 | CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact Lens | Clearlab SG Pte, Ltd. | 2008 | — |
| 0 (this device) | K102895 | One Day Flat Pack | Menicon Co, Ltd. | 2011 | — |
| +1 | 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 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (1)
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 2…ne Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lenses are substantially equivalent to the following predicate device: 1. Clear I-Day (hioxiflcon A), K080632, Manufactured by Clearlab SO Pte Ltd. Device Description: The One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact… | 2008 |
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 |
|---|---|---|---|
| K180819 | One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens | 2018 | 0 |
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 15 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K180819 (Menicon Co, Ltd., 2018) has gone furthest, with 0 descendants of its own.
- 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. 2011, 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?
The One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102895 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102895: One Day Flat Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102895
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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