Cleared Traditional

K870055 - MR590 DUAL HOSE HEATER POWER PACK

K870055 is an FDA 510(k) clearance for MR590 DUAL HOSE HEATER POWER PACK, manufactured by Fisher & Paykel Allied Products , Ltd.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K870055 · Fisher & Paykel Allied Products , Ltd. · Anesthesiology device
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Feb 1987
Decision
34d
Days
Class 2
Risk

K870055 is an FDA 510(k) clearance for the MR590 DUAL HOSE HEATER POWER PACK. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Fisher & Paykel Allied Products , Ltd. (Auckland, New Zealand, NZ). The FDA issued a Cleared decision on February 10, 1987 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K870055

510(k) Number K870055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1987
Decision Date February 10, 1987
Days to Decision 34 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 140d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTT Device Classification - Class 2, Special Controls

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 184
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K870055.
MEMBRANE HUMIDIFIER
K873472 · Respiratory Support Products, Inc. · Jan 1988
BEAR VH-820 HUMIDIFIER
K873634 · Bear Medical Systems, Inc. · Dec 1987
PREFILLED STERILE WATER FOR INHALATION, USP
K871618 · Automatic Liquid Packaging, Inc. · May 1987
COLBY LEVEL ALARM
K863955 · Respiratory Care, Inc. · Nov 1986
RESPIR THER HUMID CONTAIN STERILE WATER FOR USP
K853146 · Automatic Liquid Packaging, Inc. · Aug 1985
STERILE WATER FOR INHALATION USP 2D0799
K851940 · Travenol Laboratories, S.A. · Jun 1985
K870055 · MR590 DUAL HOSE HEATER POWER PACK
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