510(k) · Cleared
ClearedProtector Retractor & Protector Retractor with Drape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Creative Technologies, Inc. · KKX Drape, Surgical, Antimicrobial
Cleared on Apr 23, 1996 after a 186-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- Apr 23, 1996
- Review
- 186 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 4 citing it directly.
- This deviceK954824 Protector Retractor & Protector Retractor with DrapeMedical Creative Technologies, Inc. · 1996
- Descendant · cites it directly · 6 of its ownK962147 Dexterity Pneumo Sleeve SetMedical Creative Technologies, Inc. · 1996
- Descendant · 2 generations on · 5 of its ownK990414 Smith & Nephew Handport SystemSmith & Nephew, Inc. · 1999
- Descendant · 3 generations on · 4 of its ownK014047 Applied Gelport Laparoscopic Hand Access DeviceApplied Medical Resources Corp. · 2002
- Descendant · 4 generations on · 3 of its ownK090275 Gelport Single Incision Access SystemApplied Medical Resources Corp. · 2009
- Descendant · cites it directly · 3 of its ownK031889 Alexis Wound RetractorApplied Medical Resources Corp. · 2003
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K962147Dexterity Pneumo Sleeve SetMedical Creative Technologies, Inc. · 1996 · cites it directly6descendants
- K990414Smith & Nephew Handport SystemSmith & Nephew, Inc. · 1999 · 2 generations on5descendants
- K014047Applied Gelport Laparoscopic Hand Access DeviceApplied Medical Resources Corp. · 2002 · 3 generations on4descendants
- K090275Gelport Single Incision Access SystemApplied Medical Resources Corp. · 2009 · 4 generations on3descendants
- K031889Alexis Wound RetractorApplied Medical Resources Corp. · 2003 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954824 | Protector Retractor & Protector Retractor with Drape | Medical Creative Technologies, Inc. | 1996 | — |
| +1 | K962147 | Dexterity Pneumo Sleeve Set | Medical Creative Technologies, Inc. | 1996 | — |
| +2 | K990414 | Smith & Nephew Handport System | Smith & Nephew, Inc. | 1999 | — |
| +3 | K014047 | Applied Gelport Laparoscopic Hand Access Device | Applied Medical Resources Corp. | 2002 | — |
| +4 | K090275 | Gelport Single Incision Access System | Applied Medical Resources Corp. | 2009 | — |
| +1 | K031889 | Alexis Wound Retractor | Applied Medical Resources Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | — | Wound Edge Protector Drape Named without a submission number | |
| * | — | Self-Retaining Retractor Named without a submission number |
What descends from it? (14)
See all 144 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, K962147 (Medical Creative Technologies, Inc., 1996) has gone furthest, with 6 descendants 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?
This device is to be used to protect and retract an incision in the abdominal wall. This is accomplished by placing one o-ring through the incision into the peritoneum cavity while the other o-ring remains outside of the incision. The outside o-ring is then rolled down against the skin. This lines the wound to protect against contamination and holds the incision open.
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/K954824 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954824: Protector Retractor & Protector Retractor with Drape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954824
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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