Cleared Traditional

K873039 - MODEL 820 TOP=TRAK

K873039 is an FDA 510(k) clearance for MODEL 820 TOP=TRAK, manufactured by Sierra Laboratories, Inc.. The device is a Class 1 Anesthesiology device with product code BYN cleared through the Traditional 510(k) pathway after a 191-day FDA review.

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

FDA 510(k) Submission Details - K873039

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
51d slower than avg
Panel avg: 140d · This submission: 191d
Pathway characteristics
Predicate-based equivalence.

BYN Device Classification - Class 1, General Controls

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.