Cleared Traditional

K921513 - SPIROLITE MODEL MSC-201 SPIROMETER

K921513 is an FDA 510(k) clearance for SPIROLITE MODEL MSC-201 SPIROMETER, manufactured by Medical Systems Corp.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K921513 · Medical Systems Corp. · Anesthesiology device
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Jan 1993
Decision
302d
Days
Class 2
Risk

K921513 is an FDA 510(k) clearance for the SPIROLITE MODEL MSC-201 SPIROMETER. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Medical Systems Corp. (Greenvale, US). The FDA issued a Cleared decision on January 27, 1993 after a review of 302 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 Medical Systems Corp. devices

FDA 510(k) Submission Details - K921513

510(k) Number K921513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1992
Decision Date January 27, 1993
Days to Decision 302 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 140d · This submission: 302d
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 123
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K921513.
SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS
K923988 · Sensor Medics Corp. · Oct 1993
ESCORT SPIROMETER
K925085 · Vitalograph , Ltd. · Aug 1993
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
SENSORMEDICS MODEL 922 SPIROMETER
K920246 · Sensor Medics Corp. · Apr 1992