510(k) · Cleared
ClearedImc Drapes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intl. Medsurg Connection, Inc. · KKX Drape, Surgical, Antimicrobial
Cleared on Jun 7, 2005 as substantially equivalent to K030365 (Deroyal Industries, Inc., 2003) after a 97-day review. Its family tree reaches back 1 generation to 2003. 3 later devices descend from it.
- Decided
- Jun 7, 2005
- Review
- 97 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030365 (2003). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK030365 Deroyal Drapes, Sterile, Non-SterileDeroyal Industries, Inc. · 2003 · Recalled
- This deviceK050538 Imc DrapesIntl. Medsurg Connection, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK052169 Imc Surgical DrapesInternational Medsurg Connection, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK100208 Imc Surgical DrapeInternational Medsurg Connection · 2010
- Descendant · 2 generations on · 0 of its ownK070432 General Surgery DrapesWelmed, Inc. · 2007
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030365 | Deroyal Drapes, Sterile, Non-Sterile | Deroyal Industries, Inc. | 2003 | 6 |
| 0 (this device) | K050538 | Imc Drapes | Intl. Medsurg Connection, Inc. | 2005 | — |
| +1 | K052169 | Imc Surgical Drapes | International Medsurg Connection, Inc. | 2005 | — |
| +2 | K100208 | Imc Surgical Drape | International Medsurg Connection | 2010 | — |
| +2 | K070432 | General Surgery Drapes | Welmed, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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 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 |
|---|---|---|---|
| * | K030365 | Deroyal Drapes, Sterile, Non-SterileSummary page 1…cular Drapes Common Name: Surgical Drape. Classification: Class II Predicate: Surgical Drapes, Reference K030365 owned by DeRoyal Industries. Description: International Medsurg Connectio… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052169 | Imc Surgical Drapes | 2005 | 2 |
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?
- Its one ancestor has a recall.
- Of its descendants, K052169 (International Medsurg Connection, Inc., 2005) has gone furthest, with 2 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 | — |
What is it indicated for?
This device is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures.
This submission includes drapes that will be sold both sterile and non-sterile.ISO Non-sterile drapes are to be sold to OEMs for EtO sterilization according to 11135. Sterile drapes are to be sold directly to users after EtO sterilization, validated to ISO 11135.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050538: Imc Drapes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050538
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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