Cleared Traditional

K981366 - STATIC AND DYNAMIC COMPLIANCE

K981366 is an FDA 510(k) clearance for STATIC AND DYNAMIC COMPLIANCE, manufactured by Sensor Medics Corp.. The device is a Class 2 Anesthesiology device with product code BTY cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K981366 · Sensor Medics Corp. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Oct 1998
Decision
198d
Days
Class 2
Risk

K981366 is an FDA 510(k) clearance for the STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX S.... Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Sensor Medics Corp. (Yorba Linda, US). The FDA issued a Cleared decision on October 30, 1998 after a review of 198 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1890 - 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 Sensor Medics Corp. devices

FDA 510(k) Submission Details - K981366

510(k) Number K981366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1998
Decision Date October 30, 1998
Days to Decision 198 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 140d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTY Device Classification - Class 2, Special Controls

Product Code BTY Calculator, Predicted Values, Pulmonary Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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 - BTY Calculator, Predicted Values, Pulmonary Function

All 16
Devices cleared under the same product code (BTY) and FDA review panel - the closest regulatory comparables to K981366.
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VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
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FLOWSCREEN
K932744 · Erich Jaeger, Inc. · Mar 1994
MASTER SCREEN PNUEMO
K933839 · Erich Jaeger, Inc. · Mar 1994