Cleared Traditional

K935441 - INFINITECH BREATH EZ

K935441 is an FDA 510(k) clearance for INFINITECH BREATH EZ, manufactured by Infinitech, Inc.. The device is a Class 1 General & Plastic Surgery device with product code BWN cleared through the Traditional 510(k) pathway after a 87-day FDA review.

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.

FDA 510(k) Submission Details - K935441

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

BWN Device Classification - Class 1, General Controls

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.

Regulatory Peers - BWN Table And Attachments, Operating-room

All 13
Devices cleared under the same product code (BWN) and FDA review panel - the closest regulatory comparables to K935441.
AIRFRAME SURGICAL DRAPE SUPPORT
K942699 · Alpha Surgical, Inc. · Jul 1994
ISI SELF-SUPPORTING ARM
K925005 · Instrumentation Specialties, Inc. · Apr 1993
HOLDER, PEDIATRIC POSITION
K922288 · Yamashita and Hemsley Business Trust · Feb 1993
SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M
K910783 · Smith & Nephew Equipment Group · Apr 1991
BAUMER SURGICAL TABLE
K902865 · Sds Dental, Inc. · Sep 1990
IOP ADJUSTABLE STIRRUP
K884558 · Mend Technologies, Inc. · Nov 1988
K935441 · INFINITECH BREATH EZ
Download PDF Infinitech, Inc.