Cleared Traditional

K851220 - SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664 (FDA 510(k) Clearance)

Class I Anesthesiology device.

K851220 · Northern Electric Co. Div. of Sunbeam Corp. · Anesthesiology device
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Sep 1985
Decision
175d
Days
Class 1
Risk

K851220 is an FDA 510(k) clearance for the SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664. Classified as Humidifier, Non-direct Patient Interface (home-use) (product code KFZ), Class I - General Controls.

Submitted by Northern Electric Co. Div. of Sunbeam Corp. (Chicago, US). The FDA issued a Cleared decision on September 17, 1985 after a review of 175 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5460 - 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 Northern Electric Co. Div. of Sunbeam Corp. devices

Submission Details

510(k) Number K851220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1985
Decision Date September 17, 1985
Days to Decision 175 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 139d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KFZ Humidifier, Non-direct Patient Interface (home-use)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5460
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.