Cleared Traditional

MEL-PAK GENERAL DRUG DELIVERY SYSTEM KIT (K894787) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K894787 · New York Blood Center, Inc. · General Hospital
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Sep 1989
Decision
44d
Days
Class 2
Risk

K894787 is an FDA 510(k) clearance for the MEL-PAK GENERAL DRUG DELIVERY SYSTEM KIT. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by New York Blood Center, Inc. (Melville, US). The FDA issued a Cleared decision on September 13, 1989 after a review of 44 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 New York Blood Center, Inc. devices

Submission Details

510(k) Number K894787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1989
Decision Date September 13, 1989
Days to Decision 44 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
85d faster than avg
Panel avg: 129d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

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