Skip to content

MR630 Enhanced Dual Servo Heater Humidifier

by Fisher & Paykel Allied Products, Ltd.

510(k) K872138

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

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK872138 Date7 Oct 1987ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 22 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 MR630 Enhanced Dual Servo Heater Humidifier is a respiratory gas humidifier with direct patient interface, classified as a Class II medical device. It is designed to condition respiratory gases by heating and humidifying them for delivery to patients.

This device received FDA 510(k) clearance (K872138) on October 7, 1987, under product code BTT and regulation number 868.5450, with an anesthesiology advisory committee review. It is supplied as a reusable unit and is intended for use in clinical settings where respiratory gas conditioning is required.

Other devices from Fisher & Paykel Allied Products, Ltd.

See all devices from Fisher & Paykel Allied Products, Ltd. →

Questions

AI-generated answers, 22 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 is the MR630 Dual Servo Heater Humidifier used for?

    The MR630 is used to condition respiratory gases by heating and humidifying them for delivery to patients in clinical settings.

  • Is the MR630 Dual Servo Heater Humidifier reusable?

    Yes, the MR630 is supplied as a reusable unit, intended for repeated use in clinical settings where respiratory gas conditioning is required.

  • What type of clearance does the MR630 have?

    The MR630 received FDA 510(k) clearance, indicating it is substantially equivalent to a predicate device.

  • What is the product code for the MR630?

    The MR630 has a product code of BTT, under regulation number 868.5450.