Cleared Traditional

K923989 - SENSORMEDICS MODEL 6200 AUTOBOX DL

K923989 is an FDA 510(k) clearance for SENSORMEDICS MODEL 6200 AUTOBOX DL, manufactured by Sensor Medics Corp.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 363-day FDA review.

K923989 · Sensor Medics Corp. · Anesthesiology device
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Aug 1993
Decision
363d
Days
Class 2
Risk

K923989 is an FDA 510(k) clearance for the SENSORMEDICS MODEL 6200 AUTOBOX DL. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Sensor Medics Corp. (Yorba Linda, US). The FDA issued a Cleared decision on August 9, 1993 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sensor Medics Corp. devices

FDA 510(k) Submission Details - K923989

510(k) Number K923989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1992
Decision Date August 09, 1993
Days to Decision 363 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 140d · This submission: 363d
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 49
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K923989.
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K932936 · Allied Healthcare Products, Inc. · Feb 1994
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FUKUDA DENSHI MODEL SPIROSIFT SP-5000
K922428 · Fukuda Denshi USA, Inc. · Jan 1993
SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM
K920111 · Sensor Medics Corp. · Oct 1992
SENSORMEDICS MODEL 922 SPIROMETER
K920246 · Sensor Medics Corp. · Apr 1992