510(k) · Cleared
ClearedSauflon New Day (Methafilcon a) Soft (Hydrophilic) Daily Disposable Contact Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sauflon Pharmaceuticals, Ltd. · MVN Lens, Contact, (Disposable)
Cleared on May 15, 2006 as substantially equivalent to K013649 (Sauflon Pharmaceuticals, Ltd., 2001) after a 221-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- May 15, 2006
- Review
- 221 days
- Class
- Class II
- Product code
- MVN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K951893 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK951893 Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle…Permeable Technologies, Inc. · 1995
- 3 generations backK971164 Frequency 55 (Methafilcon a) Hydrophilic Contact LensAspect Vision Care, Ltd. · 1997
- 2 generations backK973063 Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily WearAspect Vision Care, Ltd. · 1997 · Recalled
- 1 generation backK013649 Sauflon 55 UV Soft (Hydrophilic) Contact LensSauflon Pharmaceuticals, Ltd. · 2001
- This deviceK052832 Sauflon New Day (Methafilcon a) Soft (Hydrophilic) Daily Disposable…Sauflon Pharmaceuticals, Ltd. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951893 | Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle Frequency 55… | Permeable Technologies, Inc. | 1995 | — |
| −3 | K971164 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens | Aspect Vision Care, Ltd. | 1997 | — |
| −2 | K973063 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily Wear | Aspect Vision Care, Ltd. | 1997 | 1 |
| −1 | K013649 | Sauflon 55 UV Soft (Hydrophilic) Contact Lens | Sauflon Pharmaceuticals, Ltd. | 2001 | — |
| 0 (this device) | K052832 | Sauflon New Day (Methafilcon a) Soft (Hydrophilic) Daily Disposable Contact… | Sauflon Pharmaceuticals, Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 MVN? 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 MVN device
- #1 K261812 HOYA Illumina (sorafilcon A) Daily Disposable…score 14.0 · 9 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 |
|---|---|---|---|
| * | K013649 | Sauflon 55 UV Soft (Hydrophilic) Contact LensSummary page 8…d in the Guidance Document for Daily Wear Contact Lenses, Revised Edition May 1994. The lens will be sterilised and packaged in the same manner as previously cleared in K013649. This lens will also be sterility released by parametric release, as cleared in K013649. INDICATIONS FOR USE The SAUFLON Ne… | 2001 |
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 11 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K013649.
How does its category compare?
All MVN devicesMVN Lens, Contact, (Disposable): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MVN
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · MVN
Too few MVN 510(k)s in any year since 2007 to give a median.
Recalls per year · MVN
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MVN
22in 2025
MAUDE reports naming product code MVN, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 1 | 9 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 1 | — | 2 | 35 |
| 2014 | 0 | — | 0 | 20 |
| 2015 | 2 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 23 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 0 | — | 0 | 34 |
| 2020 | 2 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 24 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Sauflon New Day® (methafilcon A) Soft (hydrophilic) Visibility tinted contact lens is a daily disposable lens indicated for the correction of the refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dioptres that does not interfere with visual acuity.
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/K052832 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052832: Sauflon New Day (Methafilcon a) Soft (Hydrophilic) Daily Disposable Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052832
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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