TidalPort-AP Implantable Apheresis Vascular Access Port

by Norfolk Medical Products, Inc.

510(k) K192291

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K192291↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK192291	Date20 Aug 2020Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K192291
FDA Product Code: PTD

Device Class: Class II
Regulation: 21 CFR Part 880.5965
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The TidalPort-AP Implantable Apheresis Vascular Access Port is a Subcutaneous Implanted Apheresis Port (per OpenFDA nomenclature). It is designed for repeated vascular access, facilitating long-term apheresis therapies, blood withdrawal, and infusion of medications, intravenous fluids, parenteral nutrition, blood, and blood products. The device integrates a reservoir and access mechanism to minimize complications associated with chronic vascular access.

This implantable port is supplied sterile and intended for single-use implantation beneath the skin, typically in general hospital settings. It is manufactured in three port sizes and constructed with titanium, ensuring radiopacity for imaging compatibility. The device is cleared under FDA 510(k) (K192291) as substantially equivalent to predicate devices, adhering to regulatory standards for Class II medical devices (regulation number 880.5965). Storage and handling follow sterile medical device protocols.

From the manufacturer

The Port with the Superior Reservoir Flushes easier and cleaner than any competitive port†. The introduction of the TidalPort™ line is the latest example of the spirit of innovation that thrives at Norfolk Medical as we continue the tradition of creating innovative, superior quality products.

Source: norfolkmedical.com