Cleared Traditional

K897094 - MODIFIED SPIROSCAN 1000

K897094 is an FDA 510(k) clearance for MODIFIED SPIROSCAN 1000, 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 23-day FDA review.

K897094 · Fukuda Denshi USA, Inc. · Anesthesiology device
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Jan 1990
Decision
23d
Days
Class 2
Risk

K897094 is an FDA 510(k) clearance for the MODIFIED SPIROSCAN 1000. 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 12, 1990 after a review of 23 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.

View all Fukuda Denshi USA, Inc. devices

FDA 510(k) Submission Details - K897094

510(k) Number K897094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1989
Decision Date January 12, 1990
Days to Decision 23 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
117d faster than avg
Panel avg: 140d · This submission: 23d
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 121
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K897094.
SPIRO ANALYZER MODEL ST 250
K901308 · Futuremed Div. of Future Impex Corp. · Jul 1990
FUKUDA DENSHI MODEL SPIROSIFT 3000
K900391 · Fukuda Denshi USA, Inc. · Apr 1990
SPIROSCAN 4000
K896924 · Brentwood Instruments, Inc. · Mar 1990
PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES
K895253 · Welch Allyn, Inc. · Nov 1989
PURITAN BENNETT PB900A DIAGNOSTIC SPIROMETER
K890522 · Puritan Bennett Corp. · Apr 1989
629V SPIROMETER, PULMONARY FUNCTION ANALYZER
K881402 · American Electromedics Corp. · Sep 1988