Cleared Traditional

K842634 - PFLEX RESPIRATORY MUSCLE EXERCISER

K842634 is the FDA 510(k) clearance for PFLEX RESPIRATORY MUSCLE EXERCISER by Health Scan, Inc.. It is a Class 2 Anesthesiology device (product code BWF) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K842634 · Health Scan, Inc. · Anesthesiology device
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Aug 1984
Decision
35d
Days
Class 2
Risk

K842634 is an FDA 510(k) clearance for the PFLEX RESPIRATORY MUSCLE EXERCISER. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Health Scan, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1984 after a review of 35 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Health Scan, Inc. devices

Submission Details

510(k) Number K842634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1984
Decision Date August 10, 1984
Days to Decision 35 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 140d · This submission: 35d
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 K842634.
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MOTIVATOR
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