Cleared Traditional

K900391 - FUKUDA DENSHI MODEL SPIROSIFT 3000

K900391 is an FDA 510(k) clearance for FUKUDA DENSHI MODEL SPIROSIFT 3000, 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 74-day FDA review.

K900391 · Fukuda Denshi USA, Inc. · Anesthesiology device
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Apr 1990
Decision
74d
Days
Class 2
Risk

K900391 is an FDA 510(k) clearance for the FUKUDA DENSHI MODEL SPIROSIFT 3000. 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 April 10, 1990 after a review of 74 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K900391

510(k) Number K900391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1990
Decision Date April 10, 1990
Days to Decision 74 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
66d faster than avg
Panel avg: 140d · This submission: 74d
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 K900391.
PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE
K904947 · Planmeca USA, Inc. · Jan 1991
TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)
K900331 · Ghg Medizin-Elektronik AG · Sep 1990
SPIRO ANALYZER MODEL ST 250
K901308 · Futuremed Div. of Future Impex Corp. · Jul 1990
LDW SPIROMETRY SYSTEM
K896300 · Lanpher Diagnostic Workstations, Inc. · Apr 1990
SERIAL FLOW
K900673 · Spirometrics, Inc. · Apr 1990
SPIROMETRICS MODEL 2600 MIRO SPIROMETER
K901057 · Spirometrics, Inc. · Apr 1990
K900391 · FUKUDA DENSHI MODEL SPIROSIFT 3000
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