Cleared Traditional

K904625 - SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM (FDA 510(k) Clearance)

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

K904625 · Synectics-Dantec · Anesthesiology device
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Aug 1991
Decision
314d
Days
Class 2
Risk

K904625 is an FDA 510(k) clearance for the SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Synectics-Dantec (Sweden, SE). The FDA issued a Cleared decision on August 20, 1991 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Synectics-Dantec devices

Submission Details

510(k) Number K904625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1990
Decision Date August 20, 1991
Days to Decision 314 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 139d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 227
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