Cleared Traditional

K882592 - HEART HUGGER STERNUM SUPPORT HARNESS

K882592 is an FDA 510(k) clearance for HEART HUGGER STERNUM SUPPORT HARNESS, manufactured by General Cardiac Technology, Inc.. The device is a Class 1 General Hospital device with product code KMO cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K882592 · General Cardiac Technology, Inc. · General Hospital
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Sep 1988
Decision
89d
Days
Class 1
Risk

K882592 is an FDA 510(k) clearance for the HEART HUGGER STERNUM SUPPORT HARNESS. Classified as Binder, Elastic (product code KMO), Class I - General Controls.

Submitted by General Cardiac Technology, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on September 20, 1988 after a review of 89 days - a notably fast clearance 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: 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 General Cardiac Technology, Inc. devices

FDA 510(k) Submission Details - K882592

510(k) Number K882592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1988
Decision Date September 20, 1988
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
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.