Cleared Traditional

K894556 - SPIROTEQ

K894556 is an FDA 510(k) clearance for SPIROTEQ, manufactured by System Analysis Corp.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K894556 · System Analysis Corp. · Anesthesiology device
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Jan 1990
Decision
173d
Days
Class 2
Risk

K894556 is an FDA 510(k) clearance for the SPIROTEQ. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by System Analysis Corp. (Clayes Sous Bois, France, FR). The FDA issued a Cleared decision on January 9, 1990 after a review of 173 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 - K894556

510(k) Number K894556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date January 09, 1990
Days to Decision 173 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 140d · This submission: 173d
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 178
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K894556.
MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM
K895414 · Integrated Medical Systems, Inc. · Feb 1990
WRIGHT VENTILOMETER VM-1
K895953 · Clement Clarke, Inc. · Feb 1990
MODIFIED SPIROSCAN 1000
K897094 · Fukuda Denshi USA, Inc. · Jan 1990
SCHILLER MODEL SP-100 SPIROVIT(TM)
K896120 · Schiller America, Inc. · Jan 1990
SCHILLER MODEL SP-200 SPIROVIT(TM)
K896121 · Schiller America, Inc. · Jan 1990
MULTISPIRO
K895375 · Medical Equipment Designs, Inc. · Nov 1989
K894556 · SPIROTEQ
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