510(k) · Cleared
ClearedGeneral Surgery Drapes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welmed, Inc. · KKX Drape, Surgical, Antimicrobial
Cleared on Sep 24, 2007 as substantially equivalent to K052169 (International Medsurg Connection, Inc., 2005) after a 223-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Sep 24, 2007
- Review
- 223 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K030365 (2003). No later device cites it as a predicate yet.
- Root · 3 generations backK030365 Deroyal Drapes, Sterile, Non-SterileDeroyal Industries, Inc. · 2003 · Recalled
- 2 generations backK050538 Imc DrapesIntl. Medsurg Connection, Inc. · 2005
- 1 generation backK052169 Imc Surgical DrapesInternational Medsurg Connection, Inc. · 2005
- This deviceK070432 General Surgery DrapesWelmed, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K030365 | Deroyal Drapes, Sterile, Non-Sterile | Deroyal Industries, Inc. | 2003 | 6 |
| −2 | K050538 | Imc Drapes | Intl. Medsurg Connection, Inc. | 2005 | — |
| −1 | K052169 | Imc Surgical Drapes | International Medsurg Connection, Inc. | 2005 | — |
| 0 (this device) | K070432 | General Surgery Drapes | Welmed, Inc. | 2007 | — |
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 |
|---|---|---|---|
| * | K052169 | Imc Surgical DrapesSummary page 2…Number Welmed Surgical IMC Surgical International Medsurg K052169 Drapes Drapes Connections, Inc. 5.0 Intended Uses: Surgical Drapes… | 2005 |
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 4 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K052169.
How does its category compare?
All KKX devicesKKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
Disposable sterile drapes are used in the operating room as a protective
covering, for both patient and operating room staff, from the transfer of body
fluids, micro-organisms and particulates.
Drapes provided as sterile and non-sterile.
Non-sterile surgical drapes are to be sold to OEMs for EtO sterilization according
to ISO 11135. Sterile Surgical Drapes are to be sold directly to users after EtO
sterilization validation to ISO 11135.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070432 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070432: General Surgery Drapes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070432
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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