Cleared Traditional

AQUA+TFILTERHME/THME/AQUA+TFILTERHCH/THCH (K933597) - FDA 510(k) Clearance

Class I General Hospital device.

K933597 · Arthro-Medic, Inc. · General Hospital
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Nov 1993
Decision
98d
Days
Class 1
Risk

K933597 is an FDA 510(k) clearance for the AQUA+TFILTERHME/THME/AQUA+TFILTERHCH/THCH. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Arthro-Medic, Inc. (Sweden, SE). The FDA issued a Cleared decision on November 1, 1993 after a review of 98 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5375 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Arthro-Medic, Inc. devices

Submission Details

510(k) Number K933597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1993
Decision Date November 01, 1993
Days to Decision 98 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 129d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYD Condenser, Heat And Moisture (artificial Nose)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5375
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.