Cleared Traditional

K821365 - ENGSTOM EDITH (FDA 510(k) Clearance)

Class I Anesthesiology device.

K821365 · Lkb Instruments, Inc. · Anesthesiology device
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Jun 1982
Decision
53d
Days
Class 1
Risk

K821365 is an FDA 510(k) clearance for the ENGSTOM EDITH. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Lkb Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 29, 1982 after a review of 53 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lkb Instruments, Inc. devices

Submission Details

510(k) Number K821365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1982
Decision Date June 29, 1982
Days to Decision 53 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 139d · This submission: 53d
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.