510(k) · Cleared
ClearedMTP Disposable Equipment Covers, Karl Storz 15 Touch Screen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mtp Medical Technical Promotion GmbH · MMP Cover, Barrier, Protective
Cleared on Jul 31, 2009 after a 100-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 31, 2009
- Review
- 100 days
- Class
- Class II
- Product code
- MMP
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MMP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All MMP devicesMMP Cover, Barrier, Protective: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MMP
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · MMP
Too few MMP 510(k)s in any year since 2007 to give a median.
Recalls per year · MMP
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MMP
1in 2025
MAUDE reports naming product code MMP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 5 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 1 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
MTP Disposable Equipment Covers, KARL STORZ 15" Touch Screen are intended to cover equipment used in medical settings in order to maintain a sterile field and as an aid in the clean up of equipment after surgery. The covers are not intended to be used as patient drapes and have no patient contact.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K091178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091178: MTP Disposable Equipment Covers, Karl Storz 15 Touch Screen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091178
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026