Cleared Traditional

K945118 - EXPIRATORY BREATHING EXERCISER

K945118 is an FDA 510(k) clearance for EXPIRATORY BREATHING EXERCISER, manufactured by Dhd Diemolding Healthcare Div.. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K945118 · Dhd Diemolding Healthcare Div. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
87d
Days
Class 2
Risk

K945118 is an FDA 510(k) clearance for the EXPIRATORY BREATHING EXERCISER. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Dhd Diemolding Healthcare Div. (Wampsville, US). The FDA issued a Cleared decision on January 13, 1995 after a review of 87 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.

FDA 510(k) Submission Details - K945118

510(k) Number K945118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1994
Decision Date January 13, 1995
Days to Decision 87 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 140d · This submission: 87d
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 86
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K945118.
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K945118 · EXPIRATORY BREATHING EXERCISER
Download PDF FDA Summary Dhd Diemolding Health…