Cleared Traditional

HYPO-GRIP (K780884) - FDA 510(k) Clearance

Class I General Hospital device.

K780884 · Harco Products · General Hospital
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Aug 1978
Decision
72d
Days
Class 1
Risk

K780884 is an FDA 510(k) clearance for the HYPO-GRIP. Classified as Device, Vein Location, Liquid Crystal (product code KZA), Class I - General Controls.

Submitted by Harco Products (Mchenry, US). The FDA issued a Cleared decision on August 10, 1978 after a review of 72 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6970 - 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 Harco Products devices

Submission Details

510(k) Number K780884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1978
Decision Date August 10, 1978
Days to Decision 72 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
57d faster than avg
Panel avg: 129d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZA Device, Vein Location, Liquid Crystal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6970
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.