# K954824: Protector Retractor & Protector Retractor with Drape

- Pathway: 510(k) (Traditional)
- Applicant: Medical Creative Technologies, Inc.
- Decided: Apr 23, 1996 after 186 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Wound Edge Protector Drape: named in the summary without a submission number
- (no number) Self-Retaining Retractor: named in the summary without a submission number

## Most influential descendants
- K962147: Dexterity Pneumo Sleeve Set (1996), 6 descendants of its own
- K990414: Smith & Nephew Handport System (1999), 5 descendants of its own
- K014047: Applied Gelport Laparoscopic Hand Access Device (2002), 4 descendants of its own
- K090275: Gelport Single Incision Access System (2009), 3 descendants of its own
- K031889: Alexis Wound Retractor (2003), 3 descendants of its own

## Indications for use
This device is to be used to protect and retract an incision in the abdominal wall. This is accomplished by placing one o-ring through the incision into the peritoneum cavity while the other o-ring remains outside of the incision. The outside o-ring is then rolled down against the skin. This lines the wound to protect against contamination and holds the incision open.

Source page: https://510kreport.com/device/K954824
Methodology: https://510kreport.com/methodology