Cleared Traditional

K953055 - MISTASSIST BREATHING EXERCISER

K953055 is an FDA 510(k) clearance for MISTASSIST BREATHING EXERCISER, manufactured by The Merlin Corp.. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K953055 · The Merlin Corp. · Anesthesiology device
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Feb 1996
Decision
223d
Days
Class 2
Risk

K953055 is an FDA 510(k) clearance for the MISTASSIST BREATHING EXERCISER. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by The Merlin Corp. (Camarillo, US). The FDA issued a Cleared decision on February 8, 1996 after a review of 223 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.

FDA 510(k) Submission Details - K953055

510(k) Number K953055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1995
Decision Date February 08, 1996
Days to Decision 223 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
83d slower than avg
Panel avg: 140d · This submission: 223d
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 92
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K953055.
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
PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE
K961077 · Healthscan Products, Inc. · Jul 1996
THE BREATHER
K944412 · Pal Medical, Inc. · Apr 1995
LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER
K944344 · Lung Technologies, Inc. · Feb 1995
EXPIRATORY BREATHING EXERCISER
K945118 · Dhd Diemolding Healthcare Div. · Jan 1995
K953055 · MISTASSIST BREATHING EXERCISER
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