Cleared Traditional

K922428 - FUKUDA DENSHI MODEL SPIROSIFT SP-5000

K922428 is the FDA 510(k) clearance for FUKUDA DENSHI MODEL SPIROSIFT SP-5000 by Fukuda Denshi USA, Inc.. It is a Class 2 Anesthesiology device (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.

View all Fukuda Denshi USA, Inc. devices

Submission Details

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.

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 38
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K922428.
PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
K022103 · Puritan Bennett Corp. · Sep 2002
SPIROMETER MODEL NPB-500
K980441 · Nellcor Puritan Bennett, Inc. · Apr 1998
PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE
K944762 · Puritan Bennett Corp. · Dec 1994
SPIROSIFT 500A
K904200 · Fukuda Denshi USA, Inc. · May 1991
FUKUDA DENSHI MODEL SPIROSIFT 3000
K900391 · Fukuda Denshi USA, Inc. · Apr 1990
MODIFIED SPIROSCAN 1000
K897094 · Fukuda Denshi USA, Inc. · Jan 1990