Cleared Traditional

K944412 - THE BREATHER

K944412 is the FDA 510(k) clearance for THE BREATHER by Pal Medical, Inc.. It is a Class 2 Anesthesiology device (product code BWF) cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K944412 · Pal Medical, Inc. · Anesthesiology device
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Apr 1995
Decision
230d
Days
Class 2
Risk

K944412 is an FDA 510(k) clearance for the THE BREATHER. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Pal Medical, Inc. (Orlando, US). The FDA issued a Cleared decision on April 26, 1995 after a review of 230 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5690 - 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 Pal Medical, Inc. devices

Submission Details

510(k) Number K944412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1994
Decision Date April 26, 1995
Days to Decision 230 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 140d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BWF Spirometer, Therapeutic (incentive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BWF Spirometer, Therapeutic (incentive)

All 18
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K944412.
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VersaPAP Positive Airway Pressure (PAP) Device
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VITAL PEP
K984468 · Vital Signs, Inc. · Jun 1999
ARGYLE TRU-VOL
K800386 · Sherwood Medical Co. · Feb 1980
AIR INCENTIVE SPIROMETER, W/NEBULIZER
K792217 · Airlife, Inc. · Nov 1979
MOTIVATOR
K791842 · Puritan Bennett Corp. · Oct 1979