Cleared Traditional

K853971 - REGULATOR-INHALATOR SYSTEM

K853971 is the FDA 510(k) clearance for REGULATOR-INHALATOR SYSTEM by Stephenson Industries, Inc.. It is a Class 2 Anesthesiology device (product code BTL) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K853971 · Stephenson Industries, Inc. · Anesthesiology device
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Dec 1985
Decision
74d
Days
Class 2
Risk

K853971 is an FDA 510(k) clearance for the REGULATOR-INHALATOR SYSTEM. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Stephenson Industries, Inc. (Farmingdale, US). The FDA issued a Cleared decision on December 9, 1985 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - 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 Stephenson Industries, Inc. devices

Submission Details

510(k) Number K853971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1985
Decision Date December 09, 1985
Days to Decision 74 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 140d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
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.