Cleared Traditional

THORACIC SUPPORT SYSTEM (K883214) - FDA 510(k) Clearance

Class I General Hospital device.

K883214 · Storer Medical Products · General Hospital
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Jan 1989
Decision
172d
Days
Class 1
Risk

K883214 is an FDA 510(k) clearance for the THORACIC SUPPORT SYSTEM. Classified as Binder, Elastic (product code KMO), Class I - General Controls.

Submitted by Storer Medical Products (Del Mar, US). The FDA issued a Cleared decision on January 17, 1989 after a review of 172 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5160 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Storer Medical Products devices

Submission Details

510(k) Number K883214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1988
Decision Date January 17, 1989
Days to Decision 172 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 129d · This submission: 172d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMO Binder, Elastic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5160
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.