510(k) Report

510(k) · Cleared

Cleared

Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)

K253531510(k) TraditionalCleared Feb 23, 2026102-day reviewClass II21 CFR 878.4370

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Applied Medical Resources Corporation · KGW Ring (Wound Protector), Drape Retention, Internal

Cleared on Feb 23, 2026 as substantially equivalent to K041711 (Applied Medical Resources Corp., 2004) and 1 other predicate after a 102-day review. Its family tree reaches back 1 generation to 1984. 1 later device descends from it.

Decided
Feb 23, 2026
Review
102 days
Class
Class II
Product code
KGW
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K840372 (1984). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2026: 1 descendant clearedK840372 · Flexible Illuminator 15 · Suncoast Medical Manufacturers, Inc. · 198419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant K840372 · Flexible Illuminator 15 · Suncoast Medical Manufacturers, Inc. · 19840
  1. Root · 1 generation backK840372 Flexible Illuminator 15Suncoast Medical Manufacturers, Inc. · 1984
  2. This deviceK253531 Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402)…Applied Medical Resources Corporation · 2026
  3. Descendant · cites it directly · 0 of its ownK260982 Alexis lighted wound protector-retractor, flexible, extra small…Applied Medical Resources Corporation · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K260982Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted…Applied Medical Resources Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K840372Flexible Illuminator 15Suncoast Medical Manufacturers, Inc.1984—
0 (this device)K253531Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis®…Applied Medical Resources Corporation2026—
+1K260982Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis…Applied Medical Resources Corporation2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K253531, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260982 Alexis lighted wound protector-retractor…score 11.5 · 2 generations · no Class I recall
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K041711Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304
Summary page 5
…FTF (21CFR 878.4580, Surgical lamp) Legally Marketed Predicate Devices Predicate # Predicate Trade Name Product Code K041711 Alexis Wound Retractor KGW (Primary Predicate) K840372…
Applied Medical Resources Corp.2004—
*K840372Flexible Illuminator 15
Summary page 5
…Trade Name Product Code K041711 Alexis Wound Retractor KGW (Primary Predicate) K840372 Surch-Lite FLEXIBLE FTF ILLUMINATOR 15"…
Suncoast Medical Manufacturers, Inc.1984—

Also cleared against K041711: 5 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K260982Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted…Applied Medical Resources Corporation20260

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K260982 (Applied Medical Resources Corporation, 2026) has gone furthest, with 0 descendants of its own.
  • 5 other devices also cite its predicate K041711.

How does its category compare?

All KGW devices

KGW 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

2007: 12009: 12010: 12013: 12026 (partial year): 2
2007high 2 (2026) · low 0 (2008)2026

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

2011: 12016: 122017: 582018: 132019: 112020: 122021: 42022: 182023: 132024: 192025: 15
2007high 58 (2017) · low 0 (2007)2025

MAUDE reports naming product code KGW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20091—00
20101—00
20110—01
20120—00
20131—00
20140—00
20150—00
20160—012
20170—058
20180—013
20190—011
20200—012
20210—04
20220—018
20230—013
20240—019
20250—015
20262—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 Alexis Lighted Wound Protector-Retractor is capable of temporarily…

Read the full statement (102 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 Alexis Lighted Wound Protector-Retractor is capable of temporarily closing an incision to maintain pneumoperitoneum during laparoscopic surgery, or to serve as an additional trocar port site. In addition, the device 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.

Also cleared against K041711

5 other devices cite the same predicate.

  • K140064Surgisleeve Wound ProtectorCovidien · 2014
  • K120061Wound ProtectorCovidien, Formerly US Surgical A Divison of Tyco H · 2012
  • K113496Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S · 2012
  • K111881Virtue Male Sling System and Alexis (R) Wound Retractor KitColoplast A/S · 2011
  • K093296Alexis Laparoscopic SystemApplied Medical Resources Corp. · 2009

More from Applied Medical Resources Corporation

12 FDA decisions under this applicant name. See the company

  • K260982Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound…Applied Medical Resources Corporation · 2026
  • K252412Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)Applied Medical Resources Corporation · 2025
  • K232880Inzii Ripstop Redeployable Retrieval SystemApplied Medical Resources Corporation · 2023
  • K222284Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)Applied Medical Resources Corporation · 2022
  • K220969GelPOINT V-Path Vaginal Access SystemApplied Medical Resources Corporation · 2022

Recent decisions in KGW

The KGW category page

  • K260982Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound…Applied Medical Resources Corporation · 2026
  • K113268Alexis O Wound Protector/RetractorApplied Medical Resources Corp. · 2013
  • K100120Alexis Orthopaedic Wound RetractorApplied Medical Resources Corp. · 2010
  • K093296Alexis Laparoscopic SystemApplied Medical Resources Corp. · 2009
  • K062907Alexis Wound RetractorApplied Medical Resources · 2007

https://510kreport.com/device/K253531 · printed Nov 6, 2026

Cite this page

510(k) Report. “K253531: Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253531

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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