Cleared Traditional

K961077 - PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE

K961077 is an FDA 510(k) clearance for PEP (POSITIVE EXPIRATORY PRESSURE) THER..., manufactured by Healthscan Products, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K961077

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
Combination Product No
PCCP Authorized No
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.

BWF Device Classification - Class 2, Special Controls

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 56
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K961077.
DHD EMERALD PRODUCT
K970596 · Dhd Diemolding Healthcare Div. · May 1997
MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX
K954492 · Mercury Medical · Oct 1996
THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT
K962749 · Diemolding Corp. · Oct 1996
MISTASSIST BREATHING EXERCISER
K953055 · The Merlin Corp. · Feb 1996
TVS II ELECTRONIC INCENTIVE SPIROMETER
K910138 · Monaghan Medical Corp. · Mar 1991
AEROSOL INHALATION MONITOR
K893665 · Vitalograph , Ltd. · Aug 1989