Cleared Traditional

K041900 - HC604 CPAP HUMIDIFIER

K041900 is an FDA 510(k) clearance for HC604 CPAP HUMIDIFIER, manufactured by Fisher &Paykel Healthcare , Ltd.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K041900 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology device
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Aug 2004
Decision
48d
Days
Class 2
Risk

K041900 is an FDA 510(k) clearance for the HC604 CPAP HUMIDIFIER. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on August 31, 2004 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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.

View all Fisher &Paykel Healthcare , Ltd. devices

FDA 510(k) Submission Details - K041900

510(k) Number K041900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2004
Decision Date August 31, 2004
Days to Decision 48 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 140d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 428
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K041900.
MIRAGE SWIFT
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AURA CPAP PATIENT INTERFACE
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GOODKNIGHT 425, MODELM-114500-00
K041819 · Mallinckrodt Developpement France · Jul 2004
RESMED HOSPITAL FULL FACE MASK
K041362 · Resmed, Ltd. · Jul 2004