510(k) · Cleared
ClearedMediClear PreOp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covalontechnologies, Inc. · KKX Drape, Surgical, Antimicrobial
Cleared on Sep 14, 2017 as substantially equivalent to K140250 (3M Healthcare, 2014) and 1 other predicate after a 269-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Sep 14, 2017
- Review
- 269 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K801550 (1981). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (2)
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 |
|---|---|---|---|
| * | K140250 | 3M Steri-Drape CHG Antimicrobial Incise DrapeSummary page 4…ny Device: 3M™ Steri-Drape™ CHG 3M™ Ioban™ 2 Antimicrobial Antimicrobial Incise Drape Incise Drape 510(k): K140250 K801550 Page 1 of 7… | 2014 |
| * | K801550 | 3M Germicidal Surgical Incise DrapeSummary page 4…rape™ CHG 3M™ Ioban™ 2 Antimicrobial Antimicrobial Incise Drape Incise Drape 510(k): K140250 K801550 Page 1 of 7 Covalon Technologi… | 1981 |
| † | K121819 | Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver | 2012 |
| † | K112549 | IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver | 2012 |
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?
- The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 32.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K140250.
How does its category compare?
All KKX devicesKKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
MediClear™ PreOp is indicated for use as a pre-operative (incision/insertion) drape that provides continuous antimicrobial activity to reduce the risk of contamination of the skin site by acting as an external barrier to microbial and other contamination.
MediClear™ PreOp can be left on the preoperative incision site for up to 7 days.
MediClear™ PreOp is intended to be used on intact skin and for external use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163556: MediClear PreOp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163556
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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