Cleared Traditional

K912334 - ARTEMA AQUA+ T & TS

K912334 is the FDA 510(k) clearance for ARTEMA AQUA+ T & TS by Artema Medical AB. It is a Class 1 Anesthesiology device (product code BYD) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K912334 · Artema Medical AB · Anesthesiology device
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Jul 1991
Decision
63d
Days
Class 1
Risk

K912334 is an FDA 510(k) clearance for the ARTEMA AQUA+ T & TS. 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 July 26, 1991 after a review of 63 days - a notably fast clearance cycle.

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: 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 Artema Medical AB devices

Submission Details

510(k) Number K912334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1991
Decision Date July 26, 1991
Days to Decision 63 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
77d faster than avg
Panel avg: 140d · This submission: 63d
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.

Regulatory Peers - BYD Condenser, Heat And Moisture (artificial Nose)

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