510(k) · Cleared
Recalled · 2004Deroyal Drapes, Sterile, Non-Sterile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deroyal Industries, Inc. · KKX Drape, Surgical, Antimicrobial
Cleared on Apr 29, 2003 after an 84-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it. It has been recalled 6 times.
- Decided
- Apr 29, 2003
- Review
- 84 days
- Class
- Class II
- Product code
- KKX
- Recalls
- 6
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK030365 Deroyal Drapes, Sterile, Non-SterileDeroyal Industries, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK050538 Imc DrapesIntl. Medsurg Connection, Inc. · 2005
- Descendant · 2 generations on · 2 of its ownK052169 Imc Surgical DrapesInternational Medsurg Connection, Inc. · 2005
- Descendant · 3 generations on · 0 of its ownK100208 Imc Surgical DrapeInternational Medsurg Connection · 2010
- Descendant · 3 generations on · 0 of its ownK070432 General Surgery DrapesWelmed, Inc. · 2007
Most influential descendants
Showing 4 of 4 · See all- K050538Imc DrapesIntl. Medsurg Connection, Inc. · 2005 · cites it directly3descendants
- K052169Imc Surgical DrapesInternational Medsurg Connection, Inc. · 2005 · 2 generations on2descendants
- K100208Imc Surgical DrapeInternational Medsurg Connection · 2010 · 3 generations on0descendants
- K070432General Surgery DrapesWelmed, Inc. · 2007 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030365 | Deroyal Drapes, Sterile, Non-Sterile | Deroyal Industries, Inc. | 2003 | — |
| +1 | K050538 | Imc Drapes | Intl. Medsurg Connection, Inc. | 2005 | — |
| +2 | K052169 | Imc Surgical Drapes | International Medsurg Connection, Inc. | 2005 | — |
| +3 | K100208 | Imc Surgical Drape | International Medsurg Connection | 2010 | — |
| +3 | K070432 | General Surgery Drapes | Welmed, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050538 | Imc Drapes | 2005 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 9, 2004 | Not classified | Z-1494-04 | Other | Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility. |
| Sep 9, 2004 | Not classified | Z-1490-04 | Other | Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility. |
| Sep 9, 2004 | Not classified | Z-1493-04 | Other | Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility. |
| Sep 9, 2004 | Not classified | Z-1495-04 | Other | Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility. |
| Sep 9, 2004 | Not classified | Z-1492-04 | Other | Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility. |
| Sep 9, 2004 | Not classified | Z-1491-04 | Other | Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050538 (Intl. Medsurg Connection, Inc., 2005) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K030365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030365: Deroyal Drapes, Sterile, Non-Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030365
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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