Cleared Traditional

K885313 - HUMIDI-FLEX TM (FDA 510(k) Clearance)

Class I Anesthesiology device.

K885313 · Life Design Systems, Inc. · Anesthesiology device
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Oct 1989
Decision
286d
Days
Class 1
Risk

K885313 is an FDA 510(k) clearance for the HUMIDI-FLEX TM. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Life Design Systems, Inc. (Franklin, US). The FDA issued a Cleared decision on October 11, 1989 after a review of 286 days - an extended review 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: 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 Life Design Systems, Inc. devices

Submission Details

510(k) Number K885313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1988
Decision Date October 11, 1989
Days to Decision 286 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 139d · This submission: 286d
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.