Cleared Traditional

K903489 - THERA-MIST TM VOLUMINA INCENT SPIROMETER

K903489 is an FDA 510(k) clearance for THERA-MIST TM VOLUMINA INCENT SPIROMETER, manufactured by Pegasus Research Corp.. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K903489 · Pegasus Research Corp. · Anesthesiology device
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Dec 1990
Decision
130d
Days
Class 2
Risk

K903489 is an FDA 510(k) clearance for the THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Pegasus Research Corp. (Costa Mesa, US). The FDA issued a Cleared decision on December 10, 1990 after a review of 130 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 Pegasus Research Corp. devices

FDA 510(k) Submission Details - K903489

510(k) Number K903489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1990
Decision Date December 10, 1990
Days to Decision 130 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 140d · This submission: 130d
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 K903489.
INCENTIVE SPIROMETER
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TVS II ELECTRONIC INCENTIVE SPIROMETER
K910138 · Monaghan Medical Corp. · Mar 1991
AMBU RMT VALVE
K873579 · Ambu, Inc. · Dec 1987
AIRLIFE ELECTRONIC INCENTIVE SPIROMETER
K851334 · American Pharmaseal Div. Ahsc · Aug 1985
ELECATH INFANT ARTERIAL & VENOUS CANNU
K842369 · Electro-Catheter Corp. · Aug 1984