510(k) · Cleared
ClearedDas Medical Equipment Drapes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Das Medical, LLC · KKX Drape, Surgical, Antimicrobial
Cleared on Jun 6, 2013 as substantially equivalent to K032065 (Medline Industries, Inc., 2003) and 1 other predicate after a 387-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Jun 6, 2013
- Review
- 387 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K931417 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK931417 Sterile Equipment CoversCustom Medical Products, Ltd. · 1995
- 2 generations backK961699 Equipment CoversUnited States Surgical, A Division of Tyco Healthc · 1996
- 1 generation backK052395 Sterile Equipment CoversVolcano Corporation · 2005 · Recalled
- This deviceK121436 Das Medical Equipment DrapesDas Medical, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931417 | Sterile Equipment Covers | Custom Medical Products, Ltd. | 1995 | — |
| −2 | K961699 | Equipment Covers | United States Surgical, A Division of Tyco Healthc | 1996 | — |
| −1 | K052395 | Sterile Equipment Covers | Volcano Corporation | 2005 | 2 |
| 0 (this device) | K121436 | Das Medical Equipment Drapes | Das Medical, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | K032065 | Medline Band Bags and Equipment CoversSummary page 2…nants in the clinical setting. Equipment drapes are non-patient contact. ‘Substantial Equivalency Comparison Chart Company DAS Medical, LLC Medline Volcano Corporation K032065 K052395 Design Equipment Drape ~ Various Similarities: Similarities: designs and sizes Equi valent. intended use -Differences:… | 2003 |
| * | K052395 | Sterile Equipment CoversSummary page 2…the clinical setting. Equipment drapes are non-patient contact. ‘Substantial Equivalency Comparison Chart Company DAS Medical, LLC Medline Volcano Corporation K032065 K052395 Design Equipment Drape ~ Various Similarities: Similarities: designs and sizes Equi valent. intended use -Differences: Sizes… | 2005 |
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 18 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 3 other devices also cite its predicate K032065.
How does its category compare?
All KKX devicesKKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The DAS Medical, LLC equipment drapes are used to cover a variety of equipment in the surgical and clinical areas where protection is necessary to prevent contamination of medical equipment from fluids or other contaminants in the clinical setting. Equipment drapes are non-patient contact.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121436: Das Medical Equipment Drapes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121436
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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