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 · KGW Ring (Wound Protector), Drape Retention, Internal
Cleared on Jan 9, 2007 after a 104-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jan 9, 2007
- Review
- 104 days
- Class
- Class II
- Product code
- KGW
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK062907 Alexis Wound RetractorApplied Medical Resources · 2007
- Descendant · cites it directly · 0 of its ownK100120 Alexis Orthopaedic Wound RetractorApplied Medical Resources Corp. · 2010
Most influential descendants
Showing 1 of 1 · See all- K100120Alexis Orthopaedic Wound RetractorApplied Medical Resources Corp. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062907 | Alexis Wound Retractor | Applied Medical Resources | 2007 | — |
| +1 | K100120 | Alexis Orthopaedic Wound Retractor | Applied Medical Resources Corp. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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
- #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 |
|---|---|---|---|
| * | — | OBI Mobius Named without a submission number |
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 |
|---|---|---|---|
| K100120 | Alexis Orthopaedic Wound Retractor | 2010 | 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?
- Of its descendants, K100120 (Applied Medical Resources Corp., 2010) has gone furthest, with 0 descendants of its own.
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. 2007, 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 Wound Retractor (large and extra large size only) is indicated for use to provide abdominal access during routine non-urgent cesarean deliveries. The Alexis Wound Retractor was previously cleared for the following general indications for use (K041711): • Access the abdominal cavity during surgery through an atraumatically retracted incision. • Delivery maximum exposure of the abdominal cavity with minimum incision size. • Protect against wound…
Read the full statement (114 words)
The Alexis Wound Retractor (large and extra large size only)
is indicated for use to provide abdominal access during
routine non-urgent cesarean deliveries.
The Alexis Wound Retractor was previously cleared for the
following general indications for use (K041711):
• Access the abdominal cavity during surgery through an
atraumatically retracted incision.
• Delivery maximum exposure of the abdominal cavity with minimum
incision size.
• Protect against wound contamination during laparoscopic and
open surgery.
• Seal off the incision opening to permit insufflating the
peritoneum.
• Convert the incision wound to an additional trocar port site.
• Access the thoracic cavity or other soft tissue retraction
during cardiac and general surgical procedures through an
atraumatically-retracted incision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062907 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062907: 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/K062907
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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