Cleared Traditional

K961077 - PEP (POSITIVE EXPIRATORY PRESSURE) THER...

K961077 is the FDA 510(k) clearance for PEP (POSITIVE EXPIRATORY PRESSURE) THER... by Healthscan Products, Inc.. It is a Class 2 Anesthesiology device (product code BWF) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K961077 · Healthscan Products, Inc. · Anesthesiology device
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Jul 1996
Decision
119d
Days
Class 2
Risk

K961077 is an FDA 510(k) clearance for the PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Healthscan Products, Inc. (Cedar Grove, US). The FDA issued a Cleared decision on July 15, 1996 after a review of 119 days - within the typical 510(k) review window.

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 Healthscan Products, Inc. devices

Submission Details

510(k) Number K961077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1996
Decision Date July 15, 1996
Days to Decision 119 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
21d faster than avg
Panel avg: 140d · This submission: 119d
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 K961077.
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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