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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

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
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

Devices cleared under the same product code (BWN) and FDA review panel - the closest regulatory comparables to K935441.
BAUMER SURGICAL TABLE
K902865 · Sds Dental, Inc. · Sep 1990
SPINAL SURGERY FRAME
K875291 · T. Korossurgical Instruments Corp. · Jan 1988
GUIDE TO THE KNEE
K843121 · Dyonics, Inc. · Sep 1984
AMSCO ORTHOGRAPHIC 2 TABLE
K823772 · American Sterilizer Co. · Jan 1983
THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC
K802271 · The Anspach Effort, Inc. · Oct 1980
TECNOL STIRRUPS STRAP
K791859 · Tecnol New Jersey Wound Care, Inc. · Oct 1979