510(k) · Cleared
ClearedWound Protector/Retractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources Corp. · KKX Drape, Surgical, Antimicrobial
Cleared on Apr 15, 2002 as substantially equivalent to K954824 (Medical Creative Technologies, Inc., 1996) after a 66-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Apr 15, 2002
- Review
- 66 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954824 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK954824 Protector Retractor & Protector Retractor with DrapeMedical Creative Technologies, Inc. · 1996
- This deviceK020435 Wound Protector/RetractorApplied Medical Resources Corp. · 2002
- Descendant · cites it directly · 0 of its ownK070198 Endopath Dextrus Seal Cap Assembly with Accessories and Endopath…Ethicon Endo-Surgery, LLC · 2007
Most influential descendants
Showing 1 of 1 · See all- K070198Endopath Dextrus Seal Cap Assembly with Accessories and Endopath Dextrus Fixed-Length…Ethicon Endo-Surgery, LLC · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954824 | Protector Retractor & Protector Retractor with Drape | Medical Creative Technologies, Inc. | 1996 | — |
| 0 (this device) | K020435 | Wound Protector/Retractor | Applied Medical Resources Corp. | 2002 | — |
| +1 | K070198 | Endopath Dextrus Seal Cap Assembly with Accessories and Endopath Dextrus… | Ethicon Endo-Surgery, LLC | 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 |
|---|---|---|---|
| * | K954824 | Protector Retractor & Protector Retractor with DrapeSummary page 1…Surgical drape and drape accessories). TRADE NAME: Wound Retractors PREDICATE DEVICE: Dexterity Protractor (Protector Retractor and Protector o Retractor with drape, K954824), Medical Creative Technologies, Inc. Colmar, PA. SUMMARY STATEMENT: The Applied Wound Retractor is indicated for use to retract… | 1996 |
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 |
|---|---|---|---|
| K070198 | Endopath Dextrus Seal Cap Assembly with Accessories and Endopath Dextrus Fixed-Length… | 2007 | 0 |
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?
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?
The Applied Wound Retractor is indicated for use to retract and protect an incision in the abdominal wall during both laparoscopic and open surgery. It is intended to allow the surgeon to access the abdominal cavity during surgery through an atraumatically retracted wound, providing maximum exposure with minimum incision size. In addition to incision retraction, it is intended to protect against wound contamination during both laparoscopic and open surgery.
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/K020435 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020435: Wound Protector/Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020435
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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