Cleared Traditional

MOTIVATOR (K791842) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K791842 · Puritan Bennett Corp. · Anesthesiology device
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Oct 1979
Decision
12d
Days
Class 2
Risk

K791842 is an FDA 510(k) clearance for the MOTIVATOR. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Walker, US). The FDA issued a Cleared decision on October 1, 1979 after a review of 12 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 Puritan Bennett Corp. devices

Submission Details

510(k) Number K791842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1979
Decision Date October 01, 1979
Days to Decision 12 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d faster than avg
Panel avg: 140d · This submission: 12d
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 14
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K791842.
Hudson RCI Voldyne Volumetric Exerciser
K182847 · Teleflexmedical, Inc. · Jul 2019
VersaPAP Positive Airway Pressure (PAP) Device
K173918 · Trudell Medical International · Aug 2018
ARGYLE TRU-VOL
K800386 · Sherwood Medical Co. · Feb 1980
CALCULATOR, WITH CHARGER
K781838 · C.R. Bard, Inc. · Nov 1978
RESPIRATORY EXERCISOR, VOLUME PULSE
K781669 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1978