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Heated Respiratory Humidifier HC100

by Fisher & Paykel Electronics, Ltd. New Zealand 510(k)

510(k) K915460 Product code BTT

Overview

The Heated Respiratory Humidifier HC100 is a general-purpose respiratory humidifier designed to warm and moisten gases from positive pressure breathing systems. It is intended to work with nasal CPAP systems, BiPAP systems, or equivalent CPAP or bi-level systems to humidify the air delivered to the airway.

This device is authorized via FDA 510(k) clearance. It features an anodized heater plate surface and is designed for use with respiratory gas systems.

Summary written by AI from registry data, 24 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically 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.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK915460 Date15 Jan 1993ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
BTT
FDA applicant
Fisher & Paykel Electronics , Ltd.
Device Class
Class II
Regulation
21 CFR Part 868.5450
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary function of the HC100 humidifier?

    The HC100 is a general-purpose respiratory humidifier designed to warm and moisten gases delivered through positive pressure breathing systems, such as CPAP or BiPAP units, to ensure the air reaching the patient's airway is properly humidified.

  • What type of breathing systems is this device compatible with?

    This humidifier is intended for use with nasal CPAP systems, BiPAP systems, or other equivalent CPAP or bi-level respiratory gas systems.

  • What are the key design features of the HC100?

    The device features an anodized heater plate surface, which is engineered to facilitate the warming and humidification of gases within the respiratory circuit.

  • Is this device authorized for use?

    Yes, the Heated Respiratory Humidifier HC100 is authorized via FDA 510(k) clearance, which indicates it has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K915460 24 fields · synced 22 Oct 2026