Cleared Traditional

K873540 - AEROBICA - LUNG EXERCISER

K873540 is an FDA 510(k) clearance for AEROBICA - LUNG EXERCISER, manufactured by MBA Healthcare Products, Inc.. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K873540 · MBA Healthcare Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
156d
Days
Class 2
Risk

K873540 is an FDA 510(k) clearance for the AEROBICA - LUNG EXERCISER. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by MBA Healthcare Products, Inc. (Fayetteville, US). The FDA issued a Cleared decision on February 4, 1988 after a review of 156 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 - K873540

510(k) Number K873540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1987
Decision Date February 04, 1988
Days to Decision 156 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 140d · This submission: 156d
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 K873540.
THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000
K903489 · Pegasus Research Corp. · Dec 1990
RESPIREX 2
K900754 · Diemolding Corp. · Mar 1990
AEROSOL INHALATION MONITOR
K893665 · Vitalograph , Ltd. · Aug 1989
AMBU RMT VALVE
K873579 · Ambu, Inc. · Dec 1987
AIRLIFE ELECTRONIC INCENTIVE SPIROMETER
K851334 · American Pharmaseal Div. Ahsc · Aug 1985
VITAPEP
K844963 · Vitalograph , Ltd. · Jun 1985
K873540 · AEROBICA - LUNG EXERCISER
Download PDF MBA Healthcare Produc…