Cleared Traditional

INTELLIFLOW RESPIRATORY ANALYZER (K970840) - FDA 510(k) Clearance

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

K970840 · Simtec, Inc. · Anesthesiology device
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Nov 1997
Decision
264d
Days
Class 2
Risk

K970840 is an FDA 510(k) clearance for the INTELLIFLOW RESPIRATORY ANALYZER. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Simtec, Inc. (Marion, US). The FDA issued a Cleared decision on November 26, 1997 after a review of 264 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Simtec, Inc. devices

Submission Details

510(k) Number K970840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1997
Decision Date November 26, 1997
Days to Decision 264 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 140d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 - BZC Calculator, Pulmonary Function Data

All 8
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