510(k) · Cleared
Recalled · Class II · 2026Master & Frank Surgical Drapes (Sterile)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Master & Frank Enterprses Co., Ltd. · KKX Drape, Surgical, Antimicrobial
Cleared on May 3, 2002 as substantially equivalent to K964142 (Medline Industries, Inc., 1997) after an 86-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it. It has been recalled once.
- Decided
- May 3, 2002
- Review
- 86 days
- Class
- Class II
- Product code
- KKX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964142 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK964142 Medline Disposable Surgical Drapes and GownsMedline Industries, Inc. · 1997 · Recalled
- This deviceK020393 Master & Frank Surgical Drapes (Sterile)Master & Frank Enterprses Co., Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK062480 Joykey Surgical Drapes (Sterile)Joykey Industryial, Ltd. · 2007
Most influential descendants
Showing 1 of 1 · See all- K062480Joykey Surgical Drapes (Sterile)Joykey Industryial, Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964142 | Medline Disposable Surgical Drapes and Gowns | Medline Industries, Inc. | 1997 | 3 |
| 0 (this device) | K020393 | Master & Frank Surgical Drapes (Sterile) | Master & Frank Enterprses Co., Ltd. | 2002 | — |
| +1 | K062480 | Joykey Surgical Drapes (Sterile) | Joykey Industryial, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | K964142 | Medline Disposable Surgical Drapes and GownsSummary page 3…anager) Master & Frank Surgical Drapes (Sterile) i Sterile Surgical Drapes Drape , SURGICAL Class Il 4. Predicate Device: Medline Disposable Surgical Drapes & Gowns ( K964142 ) 5. Device Description: Master & Frank Surgical Drapes (Sterile), is manufactured from non- woven fabric , PE & Reinforce lay… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062480 | Joykey Surgical Drapes (Sterile) | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 27, 2026 | Class II | Z-1889-2026 | Component change control | Unapproved design changes to the products outside of the 510(k) clearance. |
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.
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?
Master & Frank Surgical Drapes (Sterile) is a single use article intended to be used as a protective patient covering, such as to isolate a site of surgical incision for microbial and other contamination..
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/K020393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020393: Master & Frank Surgical Drapes (Sterile).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020393
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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