Cleared Traditional

K813476 - OHIO VOLUME INCENTIVE SPIROMETER

K813476 is the FDA 510(k) clearance for OHIO VOLUME INCENTIVE SPIROMETER by Airco/Ohio Medical Products. It is a Class 2 Anesthesiology device (product code BWF) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K813476 · Airco/Ohio Medical Products · Anesthesiology device
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Dec 1981
Decision
30d
Days
Class 2
Risk

K813476 is an FDA 510(k) clearance for the OHIO VOLUME INCENTIVE SPIROMETER. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Airco/Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on December 31, 1981 after a review of 30 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 Airco/Ohio Medical Products devices

Submission Details

510(k) Number K813476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1981
Decision Date December 31, 1981
Days to Decision 30 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 18
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K813476.
Hudson RCI Voldyne Volumetric Exerciser
K182847 · Teleflexmedical, Inc. · Jul 2019
VersaPAP Positive Airway Pressure (PAP) Device
K173918 · Trudell Medical International · Aug 2018
VITAL PEP
K984468 · Vital Signs, Inc. · Jun 1999
ARGYLE TRU-VOL
K800386 · Sherwood Medical Co. · Feb 1980
AIR INCENTIVE SPIROMETER, W/NEBULIZER
K792217 · Airlife, Inc. · Nov 1979
MOTIVATOR
K791842 · Puritan Bennett Corp. · Oct 1979