Cleared Traditional

K953269 - SAFECIRCUIT MANIFOLD/PULMONARY UNIT (FDA 510(k) Clearance)

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

K953269 · Advanced Warming Systems, Inc. · Anesthesiology device
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Dec 1996
Decision
526d
Days
Class 2
Risk

K953269 is an FDA 510(k) clearance for the SAFECIRCUIT MANIFOLD/PULMONARY UNIT. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Advanced Warming Systems, Inc. (Lubbock, US). The FDA issued a Cleared decision on December 20, 1996 after a review of 526 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5430 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Advanced Warming Systems, Inc. devices

Submission Details

510(k) Number K953269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1995
Decision Date December 20, 1996
Days to Decision 526 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
387d slower than avg
Panel avg: 139d · This submission: 526d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBN Apparatus, Gas-scavenging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5430
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.