Cleared Traditional

K900754 - RESPIREX 2

K900754 is an FDA 510(k) clearance for RESPIREX 2, manufactured by Diemolding Corp.. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K900754 · Diemolding Corp. · Anesthesiology device
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Mar 1990
Decision
27d
Days
Class 2
Risk

K900754 is an FDA 510(k) clearance for the RESPIREX 2. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Diemolding Corp. (Canastota, US). The FDA issued a Cleared decision on March 15, 1990 after a review of 27 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 Diemolding Corp. devices

FDA 510(k) Submission Details - K900754

510(k) Number K900754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1990
Decision Date March 15, 1990
Days to Decision 27 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 140d · This submission: 27d
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 57
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K900754.
PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE
K961077 · Healthscan Products, Inc. · Jul 1996
MISTASSIST BREATHING EXERCISER
K953055 · The Merlin Corp. · Feb 1996
TVS II ELECTRONIC INCENTIVE SPIROMETER
K910138 · Monaghan Medical Corp. · Mar 1991
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