Cleared Traditional

MODEL 510 INFANT MONITOR (K943308) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K943308 · Ge Medical Systems Information Technologies · Anesthesiology device
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Jul 1995
Decision
382d
Days
Class 2
Risk

K943308 is an FDA 510(k) clearance for the MODEL 510 INFANT MONITOR. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on July 25, 1995 after a review of 382 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 Ge Medical Systems Information Technologies devices

Submission Details

510(k) Number K943308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received July 08, 1994
Decision Date July 25, 1995
Days to Decision 382 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
242d slower than avg
Panel avg: 140d · This submission: 382d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 35
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K943308.
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