510(k) · Cleared
ClearedSurgical Drape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Griffith-Lucas, LLC · KKX Drape, Surgical, Antimicrobial
Cleared on Sep 10, 2014 as substantially equivalent to K843496 (Busse Hospital Disposables, Inc., 1984) and 2 other predicates after a 226-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Sep 10, 2014
- Review
- 226 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K031287 (2003). 4 ancestors in all, the oldest K843496 (1984). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K031287 | Steri-Drape Surgical Drapes | 3M Company | 2003 | — |
| −1 | K082297 | Busse Surgical Drape | Busse Hospital Disposables, Inc. | 2008 | — |
| 0 (this device) | K140195 | Surgical Drape | Griffith-Lucas, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 2009 | 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? (3)
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 |
|---|---|---|---|
| * | K843496 | Drape Surgical Utility Drape SterileSummary page 4…vice class: 2 Classification Names: 878.4370 Product Code: KKX Predicate Device(s): DRAPE SURGICAL UTILITY DRAPE STERILE K843496 Busse Surgical Drape I K082297 Dukal 20-001, 20-002 K 083320 Devi… | 1984 |
| * | K082297 | Busse Surgical DrapeSummary page 4…370 Product Code: KKX Predicate Device(s): DRAPE SURGICAL UTILITY DRAPE STERILE K843496 Busse Surgical Drape I K082297 Dukal 20-001, 20-002 K 083320 Device Description: Surgical drapes are intended to prov… | 2008 |
| * | K083320 | Dukal Surgical Drape; Fenestrated Dukal Surgical DrapeSummary page 4…DRAPE SURGICAL UTILITY DRAPE STERILE K843496 Busse Surgical Drape I K082297 Dukal 20-001, 20-002 K 083320 Device Description: Surgical drapes are intended to provide protection from microbial and… | 2009 |
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 11 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All KKX devicesKKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Surgical Drape is intended for external use only and is used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using ethylene oxide.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140195 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140195: Surgical Drape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140195
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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