Cleared Traditional

INFINITECH BREATH EZ (K935441) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K935441 · Infinitech, Inc. · General & Plastic Surgery device
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Feb 1994
Decision
87d
Days
Class 1
Risk

K935441 is an FDA 510(k) clearance for the INFINITECH BREATH EZ. Classified as Table And Attachments, Operating-room (product code BWN), Class I - General Controls.

Submitted by Infinitech, Inc. (St. Louis, US). The FDA issued a Cleared decision on February 7, 1994 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4950 - the FDA general and plastic surgery 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: 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 Infinitech, Inc. devices

Submission Details

510(k) Number K935441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1993
Decision Date February 07, 1994
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BWN Table And Attachments, Operating-room
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
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.