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Piper IPPB Model 2055

FDA 510(k)

Class II (US FDA 510(k))

510(k) K982016

by Vortran Medical Technology 1, Inc.

Identifiers

510(k) Number
K982016 FDA 510(k)
FDA Product Code
NHJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5905 FDA 510(k)
Regulation Number
868.5905 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Piper IPPB Model 2055 is a noncontinuous ventilator designed for intermittent positive pressure breathing (IPPB) aerosol therapy. It delivers aerosolized medication via positive pressure to adult patients weighing more than 30 kg. The device provides respiratory support through controlled pressure delivery and is operated by clinicians in clinical settings.

The Piper IPPB Model 2055 is supplied as a medical device with FDA 510(k) clearance (K982016) received on November 3, 1998. It is classified under product code NHJ and regulated under number 868.5905. The device is intended for use in anesthesiology settings and is manufactured by Vortran Medical Technology 1, Inc.

Frequently asked questions

What is the Piper IPPB Model 2055 used for?

The Piper IPPB Model 2055 is a noncontinuous ventilator designed for intermittent positive pressure breathing (IPPB) aerosol therapy. It delivers aerosolized medication via positive pressure to adult patients weighing more than 30 kg, providing respiratory support through controlled pressure delivery in clinical settings.

How is the Piper IPPB Model 2055 supplied?

The Piper IPPB Model 2055 is supplied as a medical device with FDA 510(k) clearance (K982016) received on November 3, 1998. It is classified under product code NHJ and regulated under number 868.5905, intended for use in anesthesiology settings.

Is the Piper IPPB Model 2055 reusable or single-use?

The device information does not specify whether the Piper IPPB Model 2055 is designed for single-use or reuse. As a medical device intended for clinical use, its reusability would depend on the manufacturer's instructions and facility protocols.

What are the regulatory requirements for the Piper IPPB Model 2055?

The Piper IPPB Model 2055 has FDA 510(k) clearance (K982016) received on November 3, 1998. It is classified under product code NHJ and regulated under number 868.5905, with the review advisory committee being AN (Anesthesiology).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PIPER IPPB MODEL 2055 (K982016) — FDA 510 (k) | Innolitics, Piper Ippb Model 2055 510 (k) FDA Premarket Notification K982016 ..., PDF K982016 PIPER IPPB MODEL 2055 - 510kdatabase.net, fda.innolitics.com, VORTRAN | United States | VORTRAN Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vortran Medical Technology 1, Inc.

Sources (1)

  • FDA 510(k) K982016 24 fields · synced Sep 23, 2026