510(k) · Cleared
ClearedSteri-Drape Surgical Drapes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · KKX Drape, Surgical, Antimicrobial
Cleared on Sep 10, 2003 after a 140-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Sep 10, 2003
- Review
- 140 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 7 citing it directly.
- This deviceK031287 Steri-Drape Surgical Drapes3M Company · 2003
- Descendant · cites it directly · 1 of its ownK130404 Tiburon Surgical DrapeCardinal Health200, LLC · 2013
- Descendant · cites it directly · 1 of its ownK083424 Busse Surgical DrapeBusse Hosipital Disposables · 2009
- Descendant · cites it directly · 1 of its ownK082297 Busse Surgical DrapeBusse Hospital Disposables, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK141324 Hongyu Disposable Surgical DrapesWeihai Hongyu Nonwoven Fabric Products Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK140195 Surgical DrapeGriffith-Lucas, LLC · 2014
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K130404Tiburon Surgical DrapeCardinal Health200, LLC · 2013 · cites it directly1descendant
- K083424Busse Surgical DrapeBusse Hosipital Disposables · 2009 · cites it directly1descendant
- K082297Busse Surgical DrapeBusse Hospital Disposables, Inc. · 2008 · cites it directly1descendant
- K141324Hongyu Disposable Surgical DrapesWeihai Hongyu Nonwoven Fabric Products Co., Ltd. · 2015 · 2 generations on0descendants
- K140195Surgical DrapeGriffith-Lucas, LLC · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031287 | Steri-Drape Surgical Drapes | 3M Company | 2003 | — |
| +1 | K130404 | Tiburon Surgical Drape | Cardinal Health200, LLC | 2013 | — |
| +1 | K083424 | Busse Surgical Drape | Busse Hosipital Disposables | 2009 | — |
| +1 | K082297 | Busse Surgical Drape | Busse Hospital Disposables, Inc. | 2008 | — |
| +2 | K141324 | Hongyu Disposable Surgical Drapes | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2015 | — |
| +2 | K140195 | Surgical Drape | Griffith-Lucas, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | — | Steri-Drape Fabric Surgical Drapes Named without a submission number |
What descends from it? (10)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K130404 (Cardinal Health200, LLC, 2013) has gone furthest, with 1 descendant of its own.
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?
3M Steri-DrapeTM Surgical Fabric Drapes are used to create a sterile field for a surgical procedure. They are provided sterile using ethylene oxide or gamma irradiation, and intended for external use only.
3M Steri-DrapeTM non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide processing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031287 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031287: Steri-Drape Surgical Drapes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031287
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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