Cleared Traditional

K922428 - FUKUDA DENSHI MODEL SPIROSIFT SP-5000

K922428 is an FDA 510(k) clearance for FUKUDA DENSHI MODEL SPIROSIFT SP-5000, manufactured by Fukuda Denshi USA, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K922428 · Fukuda Denshi USA, Inc. · Anesthesiology device
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Jan 1993
Decision
238d
Days
Class 2
Risk

K922428 is an FDA 510(k) clearance for the FUKUDA DENSHI MODEL SPIROSIFT SP-5000. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Fukuda Denshi USA, Inc. (Redmond, US). The FDA issued a Cleared decision on January 15, 1993 after a review of 238 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 - K922428

510(k) Number K922428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1992
Decision Date January 15, 1993
Days to Decision 238 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
98d slower than avg
Panel avg: 140d · This submission: 238d
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 227
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K922428.
SENSORMEDICS MODEL 6200 AUTOBOX DL
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FLOWSCAN
K924413 · Electrocaine Medical System · May 1993
SPIROLITE MODEL MSC-201 SPIROMETER
K921513 · Medical Systems Corp. · Jan 1993
THE KEYSTONE SYSTEM
K920877 · S & M Instrument Co. · Dec 1992
SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM
K920111 · Sensor Medics Corp. · Oct 1992
KOKO SPIROMETER
K914272 · Ferraris Respiratory, Inc. · Jul 1992
K922428 · FUKUDA DENSHI MODEL SPIROSIFT SP-5000
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