Cleared Traditional

K770690 - MASK, VAPOR, MONOMER

K770690 is an FDA 510(k) clearance for MASK, manufactured by Howmedica Corp.. The device is a Class 1 Orthopedic device with product code JDY cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K770690 · Howmedica Corp. · Orthopedic device
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Jul 1977
Decision
99d
Days
Class 1
Risk

K770690 is an FDA 510(k) clearance for the MASK, VAPOR, MONOMER. Classified as Evacuator, Vapor, Cement Monomer (product code JDY), Class I - General Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1977 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4220 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Howmedica Corp. devices

FDA 510(k) Submission Details - K770690

510(k) Number K770690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1977
Decision Date July 21, 1977
Days to Decision 99 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 122d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

JDY Device Classification - Class 1, General Controls

Product Code JDY Evacuator, Vapor, Cement Monomer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4220
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.