Cleared Traditional

K914336 - BREATHE EASY

K914336 is an FDA 510(k) clearance for BREATHE EASY, manufactured by Vital Signs, Inc.. The device is a Class 1 Anesthesiology device with product code BYD cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K914336 · Vital Signs, Inc. · Anesthesiology device
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Mar 1992
Decision
180d
Days
Class 1
Risk

K914336 is an FDA 510(k) clearance for the BREATHE EASY. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on March 25, 1992 after a review of 180 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5375 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vital Signs, Inc. devices

FDA 510(k) Submission Details - K914336

510(k) Number K914336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1991
Decision Date March 25, 1992
Days to Decision 180 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 140d · This submission: 180d
Pathway characteristics
Predicate-based equivalence.

BYD Device Classification - Class 1, General Controls

Product Code BYD Condenser, Heat And Moisture (artificial Nose)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5375
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 - BYD Condenser, Heat And Moisture (artificial Nose)

All 33
Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K914336.
VAPORTEMP HEAT AND MOISTURE EXCHANGER
K922946 · Mallinckrodt Medical · Mar 1993
5701, 5702, 5704, 5706 HYGROSCOPIC CONDENSER HUMID
K923865 · Vital Signs, Inc. · Feb 1993
HEAT MOISTURE CONDENSER
K923910 · Concord/Portex · Jan 1993
INTERTECH(TM) HEAT AND MOISTURE EXCHANGER
K903519 · Intertech Resources, Inc. · Dec 1990
HUMIDI-FLEX TM
K885313 · Life Design Systems, Inc. · Oct 1989
THERMOVENT 600, 1200, T, 02
K874597 · Portex, Inc. · Jan 1988