# K973420: Clinitex Cast Padding

- Pathway: 510(k) (Traditional)
- Applicant: Clinitex Medical Corp.
- Decided: Dec 9, 1997 after 90 days
- Product code: LGF (Component, Cast)
- Device class: 1
- Regulation: 21 CFR 888.5940
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Clinitex Cast Padding is a thin mat of interlocked textile fibers used to form a protective pad of multiple layers between the stockinette and orthopedic cast. This protective pad protects the skin, ensures that bony prominences are adequately padded to prevent undesired pressure and/or chafing from the cast and compensates for normal amounts of swelling to the affected area immediately after the injury. The polyester fibers help repel water and dry rapidly.

Source page: https://510kreport.com/device/K973420
Methodology: https://510kreport.com/methodology