510(k) · Cleared
ClearedAlexis O Wound Protector/Retractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources Corp. · KGW Ring (Wound Protector), Drape Retention, Internal
Cleared on Feb 8, 2013 as substantially equivalent to K031889 (Applied Medical Resources Corp., 2003) after a 462-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Feb 8, 2013
- Review
- 462 days
- Class
- Class II
- Product code
- KGW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954824 (1996). No later device cites it as a predicate yet.
- Root · 2 generations backK954824 Protector Retractor & Protector Retractor with DrapeMedical Creative Technologies, Inc. · 1996
- 1 generation backK031889 Alexis Wound RetractorApplied Medical Resources Corp. · 2003
- This deviceK113268 Alexis O Wound Protector/RetractorApplied Medical Resources Corp. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954824 | Protector Retractor & Protector Retractor with Drape | Medical Creative Technologies, Inc. | 1996 | — |
| −1 | K031889 | Alexis Wound Retractor | Applied Medical Resources Corp. | 2003 | — |
| 0 (this device) | K113268 | Alexis O Wound Protector/Retractor | Applied Medical Resources Corp. | 2013 | — |
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 KGW? 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 KGW device
- #1 K253531 Alexis® Lighted Wound Protector-Retractor…score 13.9 · 1 generation · 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 |
|---|---|---|---|
| * | K031889 | Alexis Wound RetractorSummary page 1…Product Code KKX PREDICATE DEVICE: Applied Medical Alexis Wound Retractor (K03 1889) DEVICE DESCRIPTION: Applied Medical's Alexis 0 wound protector/retractors are disposable single-use surgical devices used to es… | 2003 |
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 17 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K031889.
How does its category compare?
All KGW devicesKGW Ring (Wound Protector), Drape Retention, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · KGW
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KGW
Too few KGW 510(k)s in any year since 2007 to give a median.
Recalls per year · KGW
No recall names KGW since 2007.
Adverse event reports per year · KGW
15in 2025
MAUDE reports naming product code KGW, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 12 |
| 2017 | 0 | — | 0 | 58 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 0 | — | 0 | 19 |
| 2025 | 0 | — | 0 | 15 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Applied Wound Protector/Retractor is indicated for use to:
* Access the abdominal cavity during surgery through an atraumnatically retracted incision.
* Deliver maximum exposure of the abdominal cavity with minimum incision size.
* Protect against wound contamination during laparoscopic and open surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113268 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113268: Alexis O 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/K113268
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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