Cleared Traditional

DR. HESSEL'S INSECT POISON REMOVER (K844048) - FDA 510(k) Clearance

Class I General Hospital device.

K844048 · Medie Group · General Hospital
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Jan 1985
Decision
98d
Days
Class 1
Risk

K844048 is an FDA 510(k) clearance for the DR. HESSEL'S INSECT POISON REMOVER. Classified as Snake Bite Suction Kit (product code KYP), Class I - General Controls.

Submitted by Medie Group (Washington, US). The FDA issued a Cleared decision on January 23, 1985 after a review of 98 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5740 - 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.

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Submission Details

510(k) Number K844048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1984
Decision Date January 23, 1985
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYP Snake Bite Suction Kit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5740
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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.