510(k) · Cleared
ClearedLasik Eye Drape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Odyssey Medical, Inc. · KKX Drape, Surgical, Antimicrobial
Cleared on May 10, 2005 after a 194-day review. The FDA summary names its predicate without a number.
- Decided
- May 10, 2005
- Review
- 194 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 KKX? 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 KKX device
- #1 K222578 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise…score 5.7 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | — | BD Visiflex incise Drape Named without a submission number |
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.
How does its category compare?
All KKX devicesKKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KKX
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KKX
182in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KKX
2in 2024
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KKX
24in 2025
MAUDE reports naming product code KKX, 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 | 181 | 1 | 24 |
| 2008 | 5 | 164 | 0 | 24 |
| 2009 | 5 | 114 | 0 | 27 |
| 2010 | 8 | 107 | 1 | 25 |
| 2011 | 4 | 147 | 1 | 57 |
| 2012 | 2 | — | 1 | 40 |
| 2013 | 3 | 227 | 7 | 63 |
| 2014 | 6 | 182 | 7 (7) | 28 |
| 2015 | 2 | — | 0 | 33 |
| 2016 | 0 | — | 4 | 56 |
| 2017 | 1 | — | 0 | 30 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 0 | — | 0 | 41 |
| 2020 | 1 | — | 0 | 16 |
| 2021 | 1 | — | 0 | 41 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 2 | — | 0 | 32 |
| 2024 | 0 | — | 2 | 19 |
| 2025 | 0 | — | 0 | 24 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
Odyssey's L.E.D. provides a sterile adhesive surgicarbarrier for a variety of ophthalmic procedures, including LASIK. Prepare and drape the patient in the normal ophthalmic fashion. Hold back the eyelashes from the visual field as required. Care should be taken when removing the drape from the adhesive backing not to tear or damage the device. Apply the L.E.D. in the required area to provide proper occlusion and maintain a clean and dry sterile field.…
Read the full statement (144 words)
Odyssey's L.E.D. provides a sterile adhesive surgicarbarrier for a variety of ophthalmic procedures, including LASIK. Prepare and drape the patient in the normal ophthalmic fashion. Hold back the eyelashes from the visual field as required. Care should be taken when removing the drape from the adhesive backing not to tear or damage the device. Apply the L.E.D. in the required area to provide proper occlusion and maintain a clean and dry sterile field. The Lasik Eyelid Drape is designed to drape the eyebrow, completely drape the perimeter of the eye or provide complete occlusion of the eyelid. It can also be trimmed to aid in retracting lashes without obstructing the surgical site. While the adhesive holds the drape securely in place, removal is easy and painless for patients. A non-adhesive red tab is located on each side of the drape to aid in removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042977 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042977: Lasik Eye Drape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042977
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026