Cleared Traditional

K892670 - PHYSIO-DYNE EASI (EASY ANALOG SAMPLING ...

K892670 is the FDA 510(k) clearance for PHYSIO-DYNE EASI (EASY ANALOG SAMPLING ... by Physio-Dyne Instrument Corp.. It is a Class 2 Anesthesiology device (product code BZC) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K892670 · Physio-Dyne Instrument Corp. · Anesthesiology device
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Sep 1989
Decision
162d
Days
Class 2
Risk

K892670 is an FDA 510(k) clearance for the PHYSIO-DYNE EASI (EASY ANALOG SAMPLING INTERFACE). Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Physio-Dyne Instrument Corp. (Massapequa, US). The FDA issued a Cleared decision on September 22, 1989 after a review of 162 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 Physio-Dyne Instrument Corp. devices

Submission Details

510(k) Number K892670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1989
Decision Date September 22, 1989
Days to Decision 162 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 140d · This submission: 162d
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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