Cleared Traditional

K943308 - MODEL 510 INFANT MONITOR

K943308 is an FDA 510(k) clearance for MODEL 510 INFANT MONITOR, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 382-day FDA review.

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

FDA 510(k) Submission Details - K943308

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.

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 77
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K943308.
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134
K981728 · Alexander Mfg. Co. · Jun 1998
MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR
K961972 · Aequitron Medical, Inc. · Apr 1997
COROMETRICS MODEL 510 AND 511 MONITOR
K962781 · Ge Medical Systems Information Technologies · Mar 1997
MODEL 511 INFANT MONITOR
K942170 · Ge Medical Systems Information Technologies · Jun 1995
ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.
K930790 · Bio-Logic Systems Corp. · Jan 1994
MODEL MEDILOG RAPIDE
K923737 · Oxford Medilog, Inc. · Jan 1994