Skip to content

Model 3100B High Frequency Oscillatory Ventilator

by Zoll Medical Corporation

PMA P890057

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

1 closed

Documents

PMA P890057↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP890057 Date29 Mar 1991ApprovedStatusActive

Recalls

1 recall · FDA

    • Completed Z-0488-2024 FDA Class II initiated 27 Oct 2023

    Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Model 3100B High Frequency Oscillatory Ventilator (Hfov)
Trade Name
Model 3100 Frequency Oscillatory Ventilator
Generic Name
VENTILATOR, HIGH FREQUENCY
PMA Number
FDA Product Code
LSZ
Device Class
Class III
Advisory Committee
Anesthesiology
FDA Decision
APPR Approved

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 Model 3100B High Frequency Oscillatory Ventilator is a Class III medical device designed for mechanical ventilation of patients requiring high-frequency oscillatory support. It delivers rapid, small tidal volumes at high frequencies to improve gas exchange in critical care settings, particularly for conditions such as acute respiratory distress syndrome (ARDS) or neonatal respiratory failure.

This ventilator is intended for use in hospital intensive care units and is supplied as a reusable device. It operates under sterile conditions when in clinical use and must be maintained according to manufacturer guidelines. Authorized for use in the United States under FDA Premarket Approval (PMA P890057), the device adheres to regulatory standards for high-frequency ventilatory support. Storage and handling follow strict protocols to ensure device integrity and patient safety.

Other devices from Zoll Medical Corporation

See all devices from Zoll Medical Corporation →

Questions

AI-generated answers, 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.

  • What types of patients is the Model 3100B High Frequency Oscillatory Ventilator primarily designed to support in critical care settings?

    The Model 3100B is specifically designed for patients requiring high-frequency oscillatory ventilation, such as those with acute respiratory distress syndrome (ARDS) or neonatal respiratory failure. It delivers rapid, small tidal volumes at high frequencies to enhance gas exchange in intensive care environments.

  • Is the Model 3100B a single-use or reusable device, and how should it be maintained?

    The Model 3100B is a reusable device intended for use in hospital intensive care units. It must be maintained according to the manufacturer’s guidelines to ensure proper functionality and patient safety, including adherence to sterile conditions during clinical use.

  • What regulatory approval does the Model 3100B have in the United States, and when was it granted?

    The Model 3100B is authorized for use in the United States under FDA Premarket Approval (PMA P890057). This approval was granted on March 29, 1991, following a review process by the FDA’s Anesthesiology Advisory Committee (AN).

  • How should the Model 3100B be stored to ensure device integrity and patient safety?

    The Model 3100B must be stored and handled according to strict manufacturer protocols to maintain its integrity and functionality. While the data does not specify exact storage conditions, adherence to the manufacturer’s guidelines—likely including environmental controls and protection from contamination—is essential for safe and reliable operation.