Cleared Traditional

INFANT FLOW SYSTEM (K974303) - FDA 510(k) Clearance

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

K974303 · Sensor Medics Corp. · Anesthesiology device
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Jan 1998
Decision
74d
Days
Class 2
Risk

K974303 is an FDA 510(k) clearance for the INFANT FLOW SYSTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Sensor Medics Corp. (Yorba Linda, US). The FDA issued a Cleared decision on January 30, 1998 after a review of 74 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 Sensor Medics Corp. devices

Submission Details

510(k) Number K974303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1997
Decision Date January 30, 1998
Days to Decision 74 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
66d faster than avg
Panel avg: 140d · This submission: 74d
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 131
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K974303.
MONARCH II MINI MASK
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K991648 · Respironics, Inc. · May 1999
INVACARE CPAP
K982242 · Invacare Corp. · Jan 1999
QUARTET CLINICAL SYSTEM
K963761 · Respironics, Inc. · Apr 1997
BIPAP DUET SYSTEM
K964363 · Respironics, Inc. · Jan 1997
WHISPER SWIVEL II EXHALATION PORT
K962203 · Respironics, Inc. · Dec 1996