Cleared Traditional

K883214 - THORACIC SUPPORT SYSTEM

K883214 is an FDA 510(k) clearance for THORACIC SUPPORT SYSTEM, manufactured by Storer Medical Products. The device is a Class 1 General Hospital device with product code KMO cleared through the Traditional 510(k) pathway after a 172-day FDA review.

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

FDA 510(k) Submission Details - K883214

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.

KMO Device Classification - Class 1, General Controls

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.