Cleared Traditional

K853476 - T4 MONITOR STIMULATOR COMPUTER

K853476 is an FDA 510(k) clearance for T4 MONITOR STIMULATOR COMPUTER, manufactured by Regional Master Corp.. The device is a Class 2 Anesthesiology device with product code BXN cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K853476 · Regional Master Corp. · Anesthesiology device
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Jan 1986
Decision
153d
Days
Class 2
Risk

K853476 is an FDA 510(k) clearance for the T4 MONITOR STIMULATOR COMPUTER. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Regional Master Corp. (Miami, US). The FDA issued a Cleared decision on January 14, 1986 after a review of 153 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K853476

510(k) Number K853476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1985
Decision Date January 14, 1986
Days to Decision 153 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 140d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BXN Device Classification - Class 2, Special Controls

Product Code BXN Stimulator, Nerve, Battery-powered
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 - BXN Stimulator, Nerve, Battery-powered

All 37
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K853476.
MODEL MS-II MINISTIM
K870338 · Life-Tech Intl., Inc. · Mar 1987
MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR
K862149 · Puritan Bennett Corp. · Jun 1986
STIMUPLEX, NERVE STIMULATOR
K860126 · Burron Medical Products, Inc. · Feb 1986
BARD BIOMEDICAL NERVE LOCATOR
K791442 · C.R. Bard, Inc. · Sep 1979
NERVE STIMULATOR, DIGITAL PERIPHERAL
K791047 · C.R. Bard, Inc. · Jun 1979
STIMULATOR, BATTERY POWERED
K790123 · Intermedics, Inc. · Feb 1979
K853476 · T4 MONITOR STIMULATOR COMPUTER
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