# K973299: Pin Care Kit

- Pathway: 510(k) (Traditional)
- Applicant: Brown Medical Industries
- Decided: Nov 26, 1997 after 85 days
- Product code: EFQ (Gauze/Sponge, Internal)
- Device class: U
- 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 FDA summary names its predicate without a number.
- (no number) Smith + Nephew Richards Ilizarov System: named in the summary without a submission number
- (no number) AME PinCare Management System: named in the summary without a submission number

## Indications for use
The Pin Care Kit is designed for use by patients wearing external orthopedic fixation devices to help them manage their own pin site wounds.

Source page: https://510kreport.com/device/K973299
Methodology: https://510kreport.com/methodology
