Cleared Traditional

K884436 - MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 (FDA 510(k) Clearance)

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

K884436 · Harris Mfg. Co. · Chemistry device
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Dec 1988
Decision
42d
Days
Class 2
Risk

K884436 is an FDA 510(k) clearance for the MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85. Classified as Refrigerator, Freezer, Blood Storage (product code KSE), Class II - Special Controls.

Submitted by Harris Mfg. Co. (Trenton, US). The FDA issued a Cleared decision on December 2, 1988 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.9700 - the FDA in vitro diagnostics and chemistry 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 Harris Mfg. Co. devices

Submission Details

510(k) Number K884436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1988
Decision Date December 02, 1988
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KSE Refrigerator, Freezer, Blood Storage
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9700
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 Chemistry devices follow this clearance model.