Cleared Traditional

K904947 - PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE

K904947 is an FDA 510(k) clearance for PM2002 CC, manufactured by Planmeca USA, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K904947 · Planmeca USA, Inc. · Anesthesiology device
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Jan 1991
Decision
90d
Days
Class 2
Risk

K904947 is an FDA 510(k) clearance for the PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Planmeca USA, Inc. (Finland, FI). The FDA issued a Cleared decision on January 30, 1991 after a review of 90 days - within the typical 510(k) review window.

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 Planmeca USA, Inc. devices

FDA 510(k) Submission Details - K904947

510(k) Number K904947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1990
Decision Date January 30, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
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 128
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K904947.
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SPIROSIFT 500A
K904200 · Fukuda Denshi USA, Inc. · May 1991
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