510(k) · Cleared
Recalled · 20033M Germicidal Surgical Incise Drape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · KKX Drape, Surgical, Antimicrobial
Cleared on Sep 17, 1981 after a 441-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Sep 17, 1981
- Review
- 441 days
- Class
- Class II
- Product code
- KKX
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK801550 3M Germicidal Surgical Incise Drape3M Company · 1981
- Descendant · cites it directly · 2 of its ownK140250 3M Steri-Drape CHG Antimicrobial Incise Drape3M Healthcare · 2014
- Descendant · 2 generations on · 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 3 of 3 · See all- K1402503M Steri-Drape CHG Antimicrobial Incise Drape3M Healthcare · 2014 · cites it directly2descendants
- K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M Company · 2023 · 2 generations on0descendants
- K163556MediClear PreOpCovalontechnologies, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K801550 | 3M Germicidal Surgical Incise Drape | 3M Company | 1981 | — |
| +1 | K140250 | 3M Steri-Drape CHG Antimicrobial Incise Drape | 3M Healthcare | 2014 | — |
| +2 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 7, 2003 | Not classified | Z-0838-03 | Other | The product did not meet its specifications for iodine content, and had the possibility of causing moderate short-term skin irritation if used. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K140250 (3M Healthcare, 2014) 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 | — |
https://510kreport.com/device/K801550 · printed Nov 4, 2026
Cite this page
510(k) Report. “K801550: 3M Germicidal Surgical Incise Drape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K801550
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026