510(k) · Cleared
ClearedAlexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources Corporation · KGW Ring (Wound Protector), Drape Retention, Internal
Cleared on Apr 24, 2026 as substantially equivalent to K253531 (Applied Medical Resources Corporation, 2026) after a 30-day review. Its family tree reaches back 2 generations to 1984.
- Decided
- Apr 24, 2026
- Review
- 30 days
- Class
- Class II
- Product code
- KGW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K840372 (1984). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK840372 Flexible Illuminator 15Suncoast Medical Manufacturers, Inc. · 1984
- 1 generation backK253531 Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402)…Applied Medical Resources Corporation · 2026
- This deviceK260982 Alexis lighted wound protector-retractor, flexible, extra small…Applied Medical Resources Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K840372 | Flexible Illuminator 15 | Suncoast Medical Manufacturers, Inc. | 1984 | — |
| −1 | K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis®… | Applied Medical Resources Corporation | 2026 | — |
| 0 (this device) | K260982 | Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis… | Applied Medical Resources Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 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
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 |
|---|---|---|---|
| * | K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound…Summary page 6…FTF (21CFR 878.4580, Surgical lamp) Legally Marketed Predicate Devices Predicate # Predicate Trade Name Product Code K253531 Alexis® Lighted Wound KGW, FTF Protector-Retractor Device Description Sum… | 2026 |
| † | K191294 | Transvaginal Access Platform | 2019 |
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 42 years and passes through 2 companies; a new generation was cleared every 41.8 years on median.
- None of the 3 ancestors has a recall.
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. 2026, 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 Alexis lighted wound protector-retractor is a device that allows the surgeon to access the abdominal cavity through an atraumatically retracted wound, providing maximum exposure with minimum incision size. In addition to incision retraction, it is intended to provide supplemental illumination and protect against wound contamination during both laparoscopic and open surgery. The small and medium Alexis lighted wound protector-retractors are capable of…
Read the full statement (105 words)
The Alexis lighted wound protector-retractor is a device that allows the surgeon to access the abdominal cavity through an atraumatically retracted wound, providing maximum exposure with minimum incision size. In addition to incision retraction, it is intended to provide supplemental illumination and protect against wound contamination during both laparoscopic and open surgery. The small and medium Alexis lighted wound protector-retractors are capable of temporarily closing an incision to maintain pneumoperitoneum during laparoscopic surgery, or to serve as an additional trocar port site. In addition, indicated sizes may be used to access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260982 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260982: Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260982
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026