# K981229: Manan Manta Catheter Fixation Disk

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: Apr 22, 1998 after 19 days
- Product code: KNY (Accessories, Catheter, G-U)
- Device class: 2
- Regulation: 21 CFR 876.5130
- 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 K954132 (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)
- K954132: Manan Manta Catheter Fixation Disk, Manan Medical Products, Inc. (1996) Summary page 1.

## Indications for use
The Manan™ Manta Catheter Fixation Disk is intended for fixation of percutaneous drainage catheters.

Source page: https://510kreport.com/device/K981229
Methodology: https://510kreport.com/methodology