510(k) · Cleared
ClearedAlexis Wound 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 Sep 22, 2003 as substantially equivalent to K954824 (Medical Creative Technologies, Inc., 1996) after a 96-day review. Its family tree reaches back 1 generation to 1996. 3 later devices descend from it.
- Decided
- Sep 22, 2003
- Review
- 96 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954824 (1996). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK954824 Protector Retractor & Protector Retractor with DrapeMedical Creative Technologies, Inc. · 1996
- This deviceK031889 Alexis Wound RetractorApplied Medical Resources Corp. · 2003
- Descendant · cites it directly · 1 of its ownK041131 Apple Medical OB Mobius Elastic RetractorApple Medical Corp. · 2004
- Descendant · cites it directly · 0 of its ownK113268 Alexis O Wound Protector/RetractorApplied Medical Resources Corp. · 2013
- Descendant · 2 generations on · 0 of its ownK050256 Apple Medical/OB Mobius Elastic RetractorApple Medical Corp. · 2005
Most influential descendants
Showing 3 of 3 · See all- K041131Apple Medical OB Mobius Elastic RetractorApple Medical Corp. · 2004 · cites it directly1descendant
- K113268Alexis O Wound Protector/RetractorApplied Medical Resources Corp. · 2013 · cites it directly0descendants
- K050256Apple Medical/OB Mobius Elastic RetractorApple Medical Corp. · 2005 · 2 generations on0descendants
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) | K031889 | Alexis Wound Retractor | Applied Medical Resources Corp. | 2003 | — |
| +1 | K041131 | Apple Medical OB Mobius Elastic Retractor | Apple Medical Corp. | 2004 | — |
| +1 | K113268 | Alexis O Wound Protector/Retractor | Applied Medical Resources Corp. | 2013 | — |
| +2 | K050256 | Apple Medical/OB Mobius Elastic Retractor | Apple Medical Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 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…Wound Retractors PREDICATE DEVICE: Dexterity Protractor (Protector Retractor and Protector Retractor with drape, K954824), Medical Creative Technologies, Inc. Colmar, PA. DESCRIPTION The… | 1996 |
What descends from it? (3)
2 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?
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 Alexis Wound Retractor is indicated for use to:
Access the abdominal cavity during surgery through an atraumatically retracted incision.
Deliver maximum exposure of the abdominal cavity with minimum incision size.
Protect against wound contamination during laparoscopic and open surgery.
The smaller two sizes of Alexis are also intended to be used to:
Seal off the incision opening to permit insufflating the peritoneum.
Convert the incision wound to an additional trocar port site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031889: Alexis Wound Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031889
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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