# K955749: Tex-Care Sterile Stockinette

- Pathway: 510(k) (Traditional)
- Applicant: Flynt Amtex, Inc.
- Decided: Nov 22, 1996 after 339 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K822270: Various Types of Ent Elevators, Kelleher Corp. (1982). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
Sterile stockinette is used primarily as an surgical extremity drape to establish a sterile field. Bias cut sterile stockinette is used as a dressing retainer where swelling is expected.

Source page: https://510kreport.com/device/K955749
Methodology: https://510kreport.com/methodology