Cleared Traditional

K970046 - UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550) (FDA 510(k) Clearance)

Class I Anesthesiology device.

K970046 · Accutron, Inc. · Anesthesiology device
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Mar 1997
Decision
81d
Days
Class 1
Risk

K970046 is an FDA 510(k) clearance for the UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550). Classified as Mask, Scavenging (product code KHA), Class I - General Controls.

Submitted by Accutron, Inc. (Phoenix, US). The FDA issued a Cleared decision on March 28, 1997 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5590 - 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 Accutron, Inc. devices

Submission Details

510(k) Number K970046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1997
Decision Date March 28, 1997
Days to Decision 81 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
58d faster than avg
Panel avg: 139d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KHA Mask, Scavenging
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5590
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.