# K192291: TidalPort-AP Implantable Apheresis Vascular Access Port

- Pathway: 510(k) (Traditional)
- Applicant: Norfolk Medical Products, Inc.
- Decided: Aug 20, 2020 after 363 days
- Product code: PTD (Subcutaneous Implanted Apheresis Port)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K001901 (2000). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163001: PowerFlow Apheresis I.V. Port, C.R. Bard, Inc. (2017) Summary page 4.
- K112713: Norfolk Medical-Sportport-Family of Ports, Norfolk Medical Products, Inc. (2011) Summary page 5.

## Indications for use
The TidalPort-AP™ Implantable Apheresis Vascular Access Port is indicated for therapies requiring repeated access to the vascular system. The port system can be used for long-term therapeutic apheresis, withdrawal of blood, and infusion of medications, I.V. fluids, parenteral nutrition solutions, blood, and blood products. The TidalPort-AP™ Implantable Apheresis Vascular Access Port is indicated for power injection of contrast media. For power injection of contrast media, the maximium recommended infusion rate is 5 mL/s.

Source page: https://510kreport.com/device/K192291
Methodology: https://510kreport.com/methodology