Cleared Traditional

K893665 - AEROSOL INHALATION MONITOR

K893665 is an FDA 510(k) clearance for AEROSOL INHALATION MONITOR, manufactured by Vitalograph , Ltd.. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K893665 · Vitalograph , Ltd. · Anesthesiology device
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Aug 1989
Decision
98d
Days
Class 2
Risk

K893665 is an FDA 510(k) clearance for the AEROSOL INHALATION MONITOR. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on August 21, 1989 after a review of 98 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 Vitalograph , Ltd. devices

FDA 510(k) Submission Details - K893665

510(k) Number K893665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1989
Decision Date August 21, 1989
Days to Decision 98 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 140d · This submission: 98d
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 42
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K893665.
INCENTIVE SPIROMETER
K000314 · Engineered Medical Systems · Apr 2000
VITAL PEP
K984468 · Vital Signs, Inc. · Jun 1999
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
VITAPEP
K844963 · Vitalograph , Ltd. · Jun 1985