Cleared Traditional

K920246 - SENSORMEDICS MODEL 922 SPIROMETER

K920246 is an FDA 510(k) clearance for SENSORMEDICS MODEL 922 SPIROMETER, 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 78-day FDA review.

K920246 · Sensor Medics Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
78d
Days
Class 2
Risk

K920246 is an FDA 510(k) clearance for the SENSORMEDICS MODEL 922 SPIROMETER. 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 April 8, 1992 after a review of 78 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 Sensor Medics Corp. devices

FDA 510(k) Submission Details - K920246

510(k) Number K920246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1992
Decision Date April 08, 1992
Days to Decision 78 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
62d faster than avg
Panel avg: 140d · This submission: 78d
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 K920246.
SENSORMEDICS MODEL 6200 AUTOBOX DL
K923989 · Sensor Medics Corp. · Aug 1993
FUKUDA DENSHI MODEL SPIROSIFT SP-5000
K922428 · Fukuda Denshi USA, Inc. · Jan 1993
SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM
K920111 · Sensor Medics Corp. · Oct 1992
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