Cleared Traditional

K781831 - SPIROMETER

K781831 is the FDA 510(k) clearance for SPIROMETER by Hudson Oxygen Therapy Sales Co.. It is a Class 2 Anesthesiology device (product code BWF) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K781831 · Hudson Oxygen Therapy Sales Co. · Anesthesiology device
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Dec 1978
Decision
46d
Days
Class 2
Risk

K781831 is an FDA 510(k) clearance for the SPIROMETER, INCENTIVE CATALOG # 1750. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Hudson Oxygen Therapy Sales Co. (Mchenry, US). The FDA issued a Cleared decision on December 15, 1978 after a review of 46 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 Hudson Oxygen Therapy Sales Co. devices

Submission Details

510(k) Number K781831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1978
Decision Date December 15, 1978
Days to Decision 46 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 140d · This submission: 46d
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 K781831.
AIR INCENTIVE SPIROMETER, W/NEBULIZER
K792217 · Airlife, Inc. · Nov 1979
MOTIVATOR
K791842 · Puritan Bennett Corp. · Oct 1979
AIR INCENTIVE SPIROMETER
K791819 · Airlife, Inc. · Sep 1979
CALCULATOR, WITH CHARGER
K781838 · C.R. Bard, Inc. · Nov 1978
RESPIRATORY EXERCISOR, VOLUME PULSE
K781669 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1978