# K965107: Medline Admission Kits

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Mar 11, 1997 after 81 days
- Product code: FXX (Mask, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952962 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952962: EZ-Personal Protection Kit, Safetec of America, Inc. (1995) Summary page 1.

## Indications for use
Medline Personal Protection Kits are intended for use by, but not limited to, hospitals and medical centers. The original intended use of the medical products assembled in these kits will not be changed.

Source page: https://510kreport.com/device/K965107
Methodology: https://510kreport.com/methodology