510(k) · Cleared
ClearedTiburon Drape, Model 9349N/ Optima Drape, Model 9446N
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health, Inc. · KKX Drape, Surgical, Antimicrobial
Cleared on Aug 1, 2006 after a 40-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 1, 2006
- Review
- 40 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 |
|---|---|---|---|
| * | — | Convertors® Trilaminate and Optima drape materials 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?
Convertors® Surgical drapes are made from natural and synthetic materials that are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contaminated. The drape is a single use disposable device intended for repackaging and sterilization before use. This single use product is a disposable non-sterile drape designed to be repackaged and sterilized prior to use. This product maybe…
Read the full statement (172 words)
Convertors® Surgical drapes are made from natural and synthetic materials that are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contaminated. The drape is a single use disposable device intended for repackaging and sterilization before use.
This single use product is a disposable non-sterile drape designed to be repackaged and sterilized prior to use. This product maybe sterilized using Sterilization of Health Care Products-Requirements for Validation and Routine Control-Industrial Moist Heat Sterilization and Ethylene Oxide following the Validation and Routine Control under ANSI/AMMI/ISO 11134 & 11135. For more information about sterilization of this product, contact Cardinal Health Inc.
The exception for Steam sterilization is that the Trilaminate drapes, Trilaminate and Optima drapes with fluid control pouches, cannot undergo steam sterilization. Steam sterilization may cause the polyethylene in the film layer on the Trilaminate drape and the polyethylene in the fluid control pouch on these drapes to melt. Ethylene oxide is the only method of sterilization for these drapes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061762: Tiburon Drape, Model 9349N/ Optima Drape, Model 9446N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061762
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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