510(k) · Cleared
ClearedUnder Buttocks Drape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Medsurg Connection, Inc. · KKX Drape, Surgical, Antimicrobial
Cleared on Mar 11, 2005 as substantially equivalent to K842115 (Kimberly-Clark Corp., 1984) after a 143-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Mar 11, 2005
- Review
- 143 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K842115 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK842115 Spungard & Surg. Drapes-Gowns & PacksKimberly-Clark Corp. · 1984 · Recalled
- This deviceK042893 Under Buttocks DrapeInternational Medsurg Connection, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K842115 | Spungard & Surg. Drapes-Gowns & Packs | Kimberly-Clark Corp. | 1984 | 1 |
| 0 (this device) | K042893 | Under Buttocks Drape | International Medsurg Connection, Inc. | 2005 | — |
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 |
|---|---|---|---|
| * | K842115 | Spungard & Surg. Drapes-Gowns & PacksSummary page 1…ks Drapes are substantially equivalent to the Kimberly Clark Fluid Collection Under Buttocks Drape (catalog number 89414) sold by Kimberly Clark, Reference K842115. INTERNATIONAL MEDSURO CONNECTION, DNE. 510K NOTIFICATION Summary of testing: Internationa… | 1984 |
| † | K845112 | Under Buttocks Drapes |
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?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K842115.
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?
International Medsurg Connection's Fluid Collection Under Buttocks Drape is intended to be used in obstetric procedure to collect fluid and by placing under a patient's buttocks (with absorbent pad).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042893 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042893: Under Buttocks Drape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042893
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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