510(k) · Cleared
Cleared3M Steri-Drape CHG Antimicrobial Incise Drape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Healthcare · KKX Drape, Surgical, Antimicrobial
Cleared on Jul 25, 2014 as substantially equivalent to K801550 (3M Company, 1981) after a 175-day review. Its family tree reaches back 1 generation to 1981. 2 later devices descend from it.
- Decided
- Jul 25, 2014
- Review
- 175 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K801550 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK801550 3M Germicidal Surgical Incise Drape3M Company · 1981 · Recalled
- This deviceK140250 3M Steri-Drape CHG Antimicrobial Incise Drape3M Healthcare · 2014
- Descendant · cites it directly · 0 of its ownK222578 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w…3M Company · 2023
- Descendant · cites it directly · 0 of its ownK163556 MediClear PreOpCovalontechnologies, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K801550 | 3M Germicidal Surgical Incise Drape | 3M Company | 1981 | 1 |
| 0 (this device) | K140250 | 3M Steri-Drape CHG Antimicrobial Incise Drape | 3M Healthcare | 2014 | — |
| +1 | K222578 | 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | 3M Company | 2023 | — |
| +1 | K163556 | MediClear PreOp | Covalontechnologies, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K801550 | 3M Germicidal Surgical Incise DrapeSummary page 1…KKX per 21ICFR 878.4370 Predicate Device: 3MTM IobanTm 2 Antimicrobial Incise Drape (K80 1550) Description of Device: The 3MTM Steri-DrapeTrM CHO Antimicrobial Incise Drape is a sterile adhesive film that i… | 1981 |
What descends from it? (2)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KKX devicesKKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
3M Steri-Drape CHG Antimicrobial Incise Drape is indicated for use as an incise drape with continuous antimicrobial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140250: 3M Steri-Drape CHG Antimicrobial Incise Drape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140250
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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