# K970282: Medline Circumcision Tray

- Pathway: 510(k) (Traditional)
- Applicant: Medline
- Decided: Mar 6, 1997 after 41 days
- Product code: HFX (Clamp, Circumcision)
- Device class: 2
- Regulation: 21 CFR 884.4530
- 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 no predicate by number.

## Indications for use
Medline Circumcision Trays are intended for use by licensed physicians. The intended use of the medical products assembled in these kits will not be changed from the manufacturer’s original intended use.

Source page: https://510kreport.com/device/K970282
Methodology: https://510kreport.com/methodology