# K013017: Medigroup Key Tube

- Pathway: 510(k) (Traditional)
- Applicant: Janin Group, Inc.
- Decided: Dec 6, 2001 after 90 days
- Product code: FJS (Catheter, Peritoneal, Long-Term Indwelling)
- Device class: 2
- Regulation: 21 CFR 876.5630
- 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K883303: Mentor Rapid-Span (TM) Tissue Expander, Mentor Corp. (1988). Our OCR of the scanned summary read K883303, FDA’s number for Mentor Rapid-Span (TM) Tissue Expander (Mentor Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Cuff Implantor®”. Kept off the family tree. Summary page 1.

## Indications for use
The Key Tube is designed to be used to implant the Ash Advantage™ catheter. No usage change from original Ash Advantage catheter 510(k) 991042.

Source page: https://510kreport.com/device/K013017
Methodology: https://510kreport.com/methodology