Cleared Traditional

K932902 - MAGNUM

K932902 is an FDA 510(k) clearance for MAGNUM, manufactured by Sps, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K932902 · Sps, Inc. · Anesthesiology device
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May 1994
Decision
329d
Days
Class 2
Risk

K932902 is an FDA 510(k) clearance for the MAGNUM. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Sps, Inc. (Irving, US). The FDA issued a Cleared decision on May 10, 1994 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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 Sps, Inc. devices

FDA 510(k) Submission Details - K932902

510(k) Number K932902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received June 15, 1993
Decision Date May 10, 1994
Days to Decision 329 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 140d · This submission: 329d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZQ Device Classification - Class 2, Special Controls

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 - BZQ Monitor, Breathing Frequency

All 115
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K932902.
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