Cleared Traditional

K946322 - POLYGRAM SOFTWARE

K946322 is an FDA 510(k) clearance for POLYGRAM SOFTWARE, manufactured by Synectics Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K946322 · Synectics Medical, Inc. · Anesthesiology device
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Jul 1995
Decision
191d
Days
Class 2
Risk

K946322 is an FDA 510(k) clearance for the POLYGRAM SOFTWARE. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Synectics Medical, Inc. (S-116 28 Stockholm, SE). The FDA issued a Cleared decision on July 7, 1995 after a review of 191 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.

FDA 510(k) Submission Details - K946322

510(k) Number K946322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1994
Decision Date July 07, 1995
Days to Decision 191 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 140d · This submission: 191d
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 215
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K946322.
DISCOVERY GRAPHIC PORTABLE SPIROMETER
K950223 · Futuremed America, Inc. · Nov 1995
DX1
K951227 · Creative Biomedics, Inc. · Aug 1995
VITALOGRAPH MODEL 2120
K946075 · Vitalograph, Inc. · Aug 1995
PORTA-SCREEN SPIROMETER
K951367 · S & M Instrument Co. · Apr 1995
FUKUDA SANGYO MODEL SPIROANALYZER ST-180
K943546 · Spirosoft Northamerica, Inc. · Feb 1995
PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE
K944762 · Puritan Bennett Corp. · Dec 1994
K946322 · POLYGRAM SOFTWARE
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