# K032754: Vortex MP

- Pathway: 510(k) (Special)
- Applicant: Horizon Medical Products, Inc.
- Decided: Sep 12, 2003 after 7 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K994196 (2000). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994196: Horizon Medical Products Microport 2 Peripheral Access Port System, Horizon Medical Products, Inc. (2000). Our reading of the summary gave K094196, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Horizon Medical Products MicroPort 2 Peripheral Access System”.

## Most influential descendants
- K033473: Modification to Vortex MP Vascular Access Port (2003), 6 descendants of its own
- K072375: Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set (2007), 5 descendants of its own
- K081472: Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile Titanium Ports (2008), 4 descendants of its own
- K102385: Norfolk Medical Norport Family of Ports (2011), 3 descendants of its own
- K111101: Norport CT-PC, Lucent Non-Coring Needel Infusion Set (2011), 2 descendants of its own

## Recalls of this device
- Aug 30, 2010 · Not classified · Z-3072-2011: The labeling contains errors which result in the products being misbranded

## Indications for use
The Vortex@MP Peripheral Access System is indicated for peripheral placement in the mid-arm, above the antecubital space and well below the subaxillary area, when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Source page: https://510kreport.com/device/K032754
Methodology: https://510kreport.com/methodology