Cleared Traditional

K873039 - MODEL 820 TOP=TRAK (FDA 510(k) Clearance)

Class I Anesthesiology device.

K873039 · Sierra Laboratories, Inc. · Anesthesiology device
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Feb 1988
Decision
191d
Days
Class 1
Risk

K873039 is an FDA 510(k) clearance for the MODEL 820 TOP=TRAK. Classified as Chair, Posture, For Cardiac And Pulmonary Treatment (product code BYN), Class I - General Controls.

Submitted by Sierra Laboratories, Inc. (Carmel Valley, US). The FDA issued a Cleared decision on February 11, 1988 after a review of 191 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5365 - 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 Sierra Laboratories, Inc. devices

Submission Details

510(k) Number K873039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1987
Decision Date February 11, 1988
Days to Decision 191 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 139d · This submission: 191d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYN Chair, Posture, For Cardiac And Pulmonary Treatment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5365
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.