# K953529: Strato/Infusaid Life & Infuse-a-Port Implantable Port System

- Pathway: 510(k) (Traditional)
- Applicant: Strato/Infusaid, Inc.
- Decided: Jan 26, 1996 after 183 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- 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
- K112713: Norfolk Medical-Sportport-Family of Ports (2011), 1 descendant of its own
- K192291: TidalPort-AP Implantable Apheresis Vascular Access Port (2020), 0 descendants of its own

## Recalls of this device
- Sep 20, 2004 · Not classified · Z-0256-05: The product has an incorrectly sized introducer included in the kit. The kit contains a 12 French introducer instead of a 7 French introducer.

Source page: https://510kreport.com/device/K953529
Methodology: https://510kreport.com/methodology