Cleared Traditional

K896924 - SPIROSCAN 4000

K896924 is an FDA 510(k) clearance for SPIROSCAN 4000, manufactured by Brentwood Instruments, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K896924 · Brentwood Instruments, Inc. · Anesthesiology device
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Mar 1990
Decision
79d
Days
Class 2
Risk

K896924 is an FDA 510(k) clearance for the SPIROSCAN 4000. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Brentwood Instruments, Inc. (Torrange, US). The FDA issued a Cleared decision on March 1, 1990 after a review of 79 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 - K896924

510(k) Number K896924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1989
Decision Date March 01, 1990
Days to Decision 79 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
61d faster than avg
Panel avg: 140d · This submission: 79d
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 184
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K896924.
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
MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM
K895414 · Integrated Medical Systems, Inc. · Feb 1990
WRIGHT VENTILOMETER VM-1
K895953 · Clement Clarke, Inc. · Feb 1990
MODIFIED SPIROSCAN 1000
K897094 · Fukuda Denshi USA, Inc. · Jan 1990
K896924 · SPIROSCAN 4000
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