# K965112: Medline Catheterization Laboratory Trays/Kits/Packs

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Oct 10, 1997 after 294 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- 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 K962826 (1996). 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)
- K962826: Medline Radiology-Diagnostic Kits, Medline Industries, Inc. (1996) Summary page 2.
- (no number) Baxter Healthcare procedure-specific kits: named in the summary without a submission number
- (no number) Sterile Concepts procedure-specific kits: named in the summary without a submission number

## Indications for use
Medline Catheterization Laboratory Trays/Kits/Packs are intended for use by licensed physicians. The intended use of the medical products assembled in these kits will not be changed from the marufacturer’s original intended use.

Source page: https://510kreport.com/device/K965112
Methodology: https://510kreport.com/methodology