Cleared Traditional

K091557 - LUNG FLUTE THERAPEUTIC

K091557 is an FDA 510(k) clearance for LUNG FLUTE THERAPEUTIC, manufactured by Medical Acoustics. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K091557 · Medical Acoustics · Anesthesiology device
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Jan 2010
Decision
222d
Days
Class 2
Risk

K091557 is an FDA 510(k) clearance for the LUNG FLUTE THERAPEUTIC. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Medical Acoustics (Buffalo, US). The FDA issued a Cleared decision on January 4, 2010 after a review of 222 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.

View all Medical Acoustics devices

FDA 510(k) Submission Details - K091557

510(k) Number K091557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2009
Decision Date January 04, 2010
Days to Decision 222 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 140d · This submission: 222d
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 40
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K091557.
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