Cleared Traditional

K945359 - AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H (FDA 510(k) Clearance)

Class I Anesthesiology device.

K945359 · Artema Medical AB · Anesthesiology device
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Feb 1995
Decision
111d
Days
Class 1
Risk

K945359 is an FDA 510(k) clearance for the AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Artema Medical AB (Sweden, SE). The FDA issued a Cleared decision on February 21, 1995 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5375 - 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 Artema Medical AB devices

Submission Details

510(k) Number K945359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1994
Decision Date February 21, 1995
Days to Decision 111 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
28d faster than avg
Panel avg: 139d · This submission: 111d
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.