Cleared Traditional

K781792 - PRESSURIZER, EXETER CEMENT

K781792 is an FDA 510(k) clearance for PRESSURIZER, manufactured by Howmedica Corp.. The device is a Class 1 Pathology device with product code KIZ cleared through the Traditional 510(k) pathway after a 106-day FDA review.

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

FDA 510(k) Submission Details - K781792

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 77d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

KIZ Device Classification - Class 1, General Controls

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.