Cleared Traditional

K970678 - THE HARVARD LIBRARY

K970678 is an FDA 510(k) clearance for THE HARVARD LIBRARY, manufactured by Harvard Apparatus, Inc.. The device is a Class 2 General Hospital device with product code MRZ cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K970678 · Harvard Apparatus, Inc. · General Hospital
Download Printable Device Report (PDF)
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Jan 1998
Decision
319d
Days
Class 2
Risk

K970678 is an FDA 510(k) clearance for the THE HARVARD LIBRARY. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Harvard Apparatus, Inc. (South Natick, US). The FDA issued a Cleared decision on January 9, 1998 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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. Elevated predicate reliance profile. 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 Harvard Apparatus, Inc. devices

FDA 510(k) Submission Details - K970678

510(k) Number K970678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1997
Decision Date January 09, 1998
Days to Decision 319 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 129d · This submission: 319d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRZ Device Classification - Class 2, Special Controls

Product Code MRZ Accessories, Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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.

Regulatory Peers - MRZ Accessories, Pump, Infusion

All 21
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