Cleared Traditional

K970959 - INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT) (FDA 510(k) Clearance)

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

K970959 · Instrumentation Industries, Inc. · Anesthesiology device
Jun 1997
Decision
88d
Days
Class 2
Risk

K970959 is an FDA 510(k) clearance for the INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT). Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on June 13, 1997 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - 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.

Submission Details

510(k) Number K970959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1997
Decision Date June 13, 1997
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Regulatory Context
Review time vs. panel average
137d faster than avg
Panel avg: 225d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
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.