Cleared Traditional

K913395 - EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS

K913395 is an FDA 510(k) clearance for EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS, manufactured by Pro-Tech, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K913395 · Pro-Tech, Inc. · Anesthesiology device
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May 1992
Decision
295d
Days
Class 2
Risk

K913395 is an FDA 510(k) clearance for the EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Pro-Tech, Inc. (Woodinville, US). The FDA issued a Cleared decision on May 20, 1992 after a review of 295 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - 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 Pro-Tech, Inc. devices

FDA 510(k) Submission Details - K913395

510(k) Number K913395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1991
Decision Date May 20, 1992
Days to Decision 295 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
155d slower than avg
Panel avg: 140d · This submission: 295d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZG Device Classification - Class 2, Special Controls

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
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 - BZG Spirometer, Diagnostic

All 149
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K913395.
SENSORMEDICS MODEL 6200 AUTOBOX DL
K923989 · Sensor Medics Corp. · Aug 1993
FUKUDA DENSHI MODEL SPIROSIFT SP-5000
K922428 · Fukuda Denshi USA, Inc. · Jan 1993
SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM
K920111 · Sensor Medics Corp. · Oct 1992
SENSORMEDICS MODEL 922 SPIROMETER
K920246 · Sensor Medics Corp. · Apr 1992
AIRWAY THERMISTOR
K914219 · Synectics-Dantec · Feb 1992
VITALOGRAPH SPIROTRAC III
K912412 · Vitalograph , Ltd. · Oct 1991