510(k) · Cleared
ClearedAirperm (Siflufocon a) Rigid Gas Permeable OK Contact Lenses for Daily Wear Orthokeratology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airperm, Inc. · MUW Lens, Contact (Orthokeratology)
Cleared on Apr 8, 1998 after a 194-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Apr 8, 1998
- Review
- 194 days
- Class
- Class II
- Product code
- MUW
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK973697 Airperm (Siflufocon a) Rigid Gas Permeable OK Contact Lenses for…Airperm, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK160859 OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)Contamac, Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K160859OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)Contamac, Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973697 | Airperm (Siflufocon a) Rigid Gas Permeable OK Contact Lenses for Daily Wear… | Airperm, Inc. | 1998 | — |
| +1 | K160859 | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) | Contamac, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MUW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | predicate lens of rigid contact lens material Named without a submission number |
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 |
|---|---|---|---|
| K160859 | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) | 2016 | 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?
- Of its descendants, K160859 (Contamac, Ltd., 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MUW devicesMUW Lens, Contact (Orthokeratology): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUW
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · MUW
Too few MUW 510(k)s in any year since 2007 to give a median.
Recalls per year · MUW
No recall names MUW since 2007.
Adverse event reports per year · MUW
1in 2023
MAUDE reports naming product code MUW, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CONTEX OK™ (siflufocon A) Rigid Gas Permeable Contact Lens for Orthokeratology is indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lens is indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 3.00 diopters. The lens may be disinfected using a chemical disinfection system only.
Note: To maintain the orthokeratology effect of myopia reduction lens wear must be continued on a prescribed wearing schedule.
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/K973697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973697: Airperm (Siflufocon a) Rigid Gas Permeable OK Contact Lenses for Daily Wear Orthokeratology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973697
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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