Cleared Traditional

MODEL 7410 VOYAGER (K974879) - FDA 510(k) Clearance

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

K974879 · Healthdyne Technologies, Inc. · Anesthesiology device
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Jun 1998
Decision
181d
Days
Class 2
Risk

K974879 is an FDA 510(k) clearance for the MODEL 7410 VOYAGER. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Healthdyne Technologies, Inc. (Marietta, US). The FDA issued a Cleared decision on June 29, 1998 after a review of 181 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Healthdyne Technologies, Inc. devices

Submission Details

510(k) Number K974879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1997
Decision Date June 29, 1998
Days to Decision 181 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 140d · This submission: 181d
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 K974879.
INVACARE CPAP
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K982530 · Resmed, Ltd. · Oct 1998
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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