# K962849: Catheter Insertion Tray

- Pathway: 510(k) (Traditional)
- Applicant: Medcare Medical Group, Inc.
- Decided: Oct 7, 1996 after 77 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- 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 K936261 (1994). 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)
- K936261: Catheter Insertion Tray, Medcare Custom Packaging, Inc. (1994) Summary page 1.
- (no number) Prep Tray - PICC Insertion Cat No. DP2-2150: named in the summary without a submission number

## Indications for use
The Catheter Insertion Tray is a single patient, single use, disposable device which is intended to conveniently provide components to aid in the administration of percutaneous catheterization.

Source page: https://510kreport.com/device/K962849
Methodology: https://510kreport.com/methodology