Cleared Traditional

K941547 - CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT (FDA 510(k) Clearance)

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

K941547 · Allied Healthcare Products, Inc. · Anesthesiology device
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Mar 1995
Decision
336d
Days
Class 2
Risk

K941547 is an FDA 510(k) clearance for the CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT. Classified as Tent, Oxygen, Electrically Powered (product code BYK), Class II - Special Controls.

Submitted by Allied Healthcare Products, Inc. (Saint Louis, US). The FDA issued a Cleared decision on March 1, 1995 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5710 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K941547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1994
Decision Date March 01, 1995
Days to Decision 336 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
197d slower than avg
Panel avg: 139d · This submission: 336d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BYK Tent, Oxygen, Electrically Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5710
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.