Cleared Traditional

CPAP HUMIDIFIER (HC 200) (K973161) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K973161 · Fisher & Paykel Electronics , Ltd. · Anesthesiology device
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Jul 1998
Decision
322d
Days
Class 2
Risk

K973161 is an FDA 510(k) clearance for the CPAP HUMIDIFIER (HC 200). Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Fisher & Paykel Electronics , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on July 10, 1998 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fisher & Paykel Electronics , Ltd. devices

Submission Details

510(k) Number K973161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1997
Decision Date July 10, 1998
Days to Decision 322 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
182d slower than avg
Panel avg: 140d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 208
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K973161.
INVACARE CPAP
K982242 · Invacare Corp. · Jan 1999
SULLIVAN MIRAGE FULL FACE MASK
K982530 · Resmed, Ltd. · Oct 1998
SULLIVAN AUTOSET
K980721 · Resmed, Ltd. · Sep 1998
SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM
K970771 · Resmed, Ltd. · Jun 1997
SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM
K970516 · Resmed, Ltd. · May 1997
QUARTET CLINICAL SYSTEM
K963761 · Respironics, Inc. · Apr 1997