Cleared Traditional

K081693 - NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS (FDA 510(k) Clearance)

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

K081693 · Instrumentation Industries, Inc. · Anesthesiology device
Sep 2008
Decision
86d
Days
Class 2
Risk

K081693 is an FDA 510(k) clearance for the NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS. Classified as Meter, Airway Pressure (inspiratory Force) (product code BXR), Class II - Special Controls.

Submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on September 11, 2008 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1780 - 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 K081693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2008
Decision Date September 11, 2008
Days to Decision 86 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
139d faster than avg
Panel avg: 225d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BXR Meter, Airway Pressure (inspiratory Force)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1780
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.