Cleared Traditional

K955026 - AS/3 NMT MODULE (FDA 510(k) Clearance)

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

K955026 · Datex Medical Instrumentation, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
543d
Days
Class 2
Risk

K955026 is an FDA 510(k) clearance for the AS/3 NMT MODULE. Classified as Stimulator, Nerve, Peripheral, Electric (product code KOI), Class II - Special Controls.

Submitted by Datex Medical Instrumentation, Inc. (Tewksbury, US). The FDA issued a Cleared decision on April 28, 1997 after a review of 543 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2775 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Datex Medical Instrumentation, Inc. devices

Submission Details

510(k) Number K955026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1995
Decision Date April 28, 1997
Days to Decision 543 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
404d slower than avg
Panel avg: 139d · This submission: 543d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOI Stimulator, Nerve, Peripheral, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2775
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 - KOI Stimulator, Nerve, Peripheral, Electric

All 27
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