Cleared Traditional

K781792 - PRESSURIZER, EXETER CEMENT (FDA 510(k) Clearance)

Class I Pathology device.

K781792 · Howmedica Corp. · Pathology device
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Feb 1979
Decision
106d
Days
Class 1
Risk

K781792 is an FDA 510(k) clearance for the PRESSURIZER, EXETER CEMENT. Classified as Dish, Tissue Culture (product code KIZ), Class I - General Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on February 8, 1979 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2240 - the FDA pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Howmedica Corp. devices

Submission Details

510(k) Number K781792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1978
Decision Date February 08, 1979
Days to Decision 106 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 77d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIZ Dish, Tissue Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2240
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.