Cleared Traditional

K851666 - MEDI-COMP NEONATAL OXYGEN HOOD (FDA 510(k) Clearance)

Class I Anesthesiology device.

K851666 · Medicomp, Inc. · Anesthesiology device
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Aug 1985
Decision
105d
Days
Class 1
Risk

K851666 is an FDA 510(k) clearance for the MEDI-COMP NEONATAL OXYGEN HOOD. Classified as Tent, Oxygen (product code BYL), Class I - General Controls.

Submitted by Medicomp, Inc. (Anoka, US). The FDA issued a Cleared decision on August 6, 1985 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5700 - 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 Medicomp, Inc. devices

Submission Details

510(k) Number K851666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1985
Decision Date August 06, 1985
Days to Decision 105 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 139d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYL Tent, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5700
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.