510(k) · Cleared
Recalled · Class II · 2025Kimberly-Clark KC100 Surgical Drapes, Model KC 100, Kimberly-Clark KC100 Surgical Equipment Covers, Model KC 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Corp. · KKX Drape, Surgical, Antimicrobial
Cleared on Mar 25, 2009 as substantially equivalent to K080629 (Promedical Products Co., Ltd., 2008) after a 142-day review. Its family tree reaches back 1 generation to 2008. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 25, 2009
- Review
- 142 days
- Class
- Class II
- Product code
- KKX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K080629 (2008). 5 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK080629 Promedical Surgical Drapes, Promedical Surgical Mayo Stand Cover…Promedical Products Co., Ltd. · 2008
- This deviceK083234 Kimberly-Clark KC100 Surgical Drapes, Model KC 100, Kimberly-Clark…Kimberly-Clark Corp. · 2009
- Descendant · cites it directly · 1 of its ownK102666 Kimberly-Clark Surgical Drapes with Aami Liquid Barrier Level 4 ClaimKimberly-Clark Corp. · 2010
- Descendant · 2 generations on · 0 of its ownK121919 Surgical Drape with Aami Liquid Barrier Level IVExact Medical Manufacturing, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK111458 Gri Sterile and Non-Sterile Surgical Drapes and Surgical Equipment…Gri Medical & Electronic Technology Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK101689 Emm Equipment Cover-PolythyleneExact Medical Manufacturing, Inc. · 2010 · Recalled
- Descendant · cites it directly · 0 of its ownK093909 Busse Surgical Drapes IVBusse Hospital Disposables, Inc. · 2010
Most influential descendants
Showing 5 of 5 · See all- K102666Kimberly-Clark Surgical Drapes with Aami Liquid Barrier Level 4 ClaimKimberly-Clark Corp. · 2010 · cites it directly1descendant
- K121919Surgical Drape with Aami Liquid Barrier Level IVExact Medical Manufacturing, Inc. · 2013 · 2 generations on0descendants
- K111458Gri Sterile and Non-Sterile Surgical Drapes and Surgical Equipment CoversGri Medical & Electronic Technology Co., Ltd. · 2011 · cites it directly0descendants
- K101689Emm Equipment Cover-PolythyleneExact Medical Manufacturing, Inc. · 2010 · cites it directly0descendants
- K093909Busse Surgical Drapes IVBusse Hospital Disposables, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K080629 | Promedical Surgical Drapes, Promedical Surgical Mayo Stand Cover, Band Bags | Promedical Products Co., Ltd. | 2008 | — |
| 0 (this device) | K083234 | Kimberly-Clark KC100 Surgical Drapes, Model KC 100, Kimberly-Clark KC100… | Kimberly-Clark Corp. | 2009 | — |
| +1 | K102666 | Kimberly-Clark Surgical Drapes with Aami Liquid Barrier Level 4 Claim | Kimberly-Clark Corp. | 2010 | — |
| +2 | K121919 | Surgical Drape with Aami Liquid Barrier Level IV | Exact Medical Manufacturing, Inc. | 2013 | — |
| +1 | K111458 | Gri Sterile and Non-Sterile Surgical Drapes and Surgical Equipment Covers | Gri Medical & Electronic Technology Co., Ltd. | 2011 | — |
| +1 | K101689 | Emm Equipment Cover-Polythylene | Exact Medical Manufacturing, Inc. | 2010 | 1 |
| +1 | K093909 | Busse Surgical Drapes IV | Busse Hospital Disposables, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K080629 | Promedical Surgical Drapes, Promedical Surgical Mayo Stand Cover, Band BagsSummary page 1…hat are intended to be used to cover surgical equipment and provide a protective barrier for that equipment. Predicate K080629 proMedical Surgical Drapes and proMedical Devices: Surgical Equipment Covers Substantial The surgical drapes… | 2008 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 17, 2025 | Class II | Z-2520-2025 | Process control | Surgical drape packs may have open seals, which may compromise the sterility of the product. |
| Nov 26, 2024 | Class II | Z-0983-2025 | Process control | Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K102666 (Kimberly-Clark Corp., 2010) has gone furthest, with 1 descendant 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. 2009, 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?
Kimberly-Clark* Corporation intends to market the sterile KC100 Surgical Equipment Covers which are protective barrier covers that are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.
Kimberly-Clark* Corporation intends to market the sterile KC100 Surgical Drapes as devices made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083234 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083234: Kimberly-Clark KC100 Surgical Drapes, Model KC 100, Kimberly-Clark KC100 Surgical Equipment Covers, Model KC 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083234
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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