Cleared Traditional

K904025 - MYOTRACK, MODEL HH 515

K904025 is an FDA 510(k) clearance for MYOTRACK, manufactured by Myotrack Co.. The device is a Class 2 Anesthesiology device with product code BXN cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K904025 · Myotrack Co. · Anesthesiology device
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Mar 1991
Decision
183d
Days
Class 2
Risk

K904025 is an FDA 510(k) clearance for the MYOTRACK, MODEL HH 515. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Myotrack Co. (Van Nuys, US). The FDA issued a Cleared decision on March 1, 1991 after a review of 183 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 - K904025

510(k) Number K904025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1990
Decision Date March 01, 1991
Days to Decision 183 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 140d · This submission: 183d
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 36
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K904025.
SENSI-TOUCH EPIDURAL ANESTHESIA FILTER
K954525 · Sherwood Medical Co. · Jan 1996
MS-III MINISTIM
K913184 · Life-Tech Intl., Inc. · Oct 1991
NEUROMUSCULAR TRANSMISSION MONITOR
K905092 · Utah Medical Products, Inc. · Jun 1991
MODIFIED AXOSTIM
K896368 · Singer Medical Products, Inc. · Nov 1989
BIO-INDUSTRY STIM POCHE(R)
K894786 · The Hader Corp. · Sep 1989
ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR
K893485 · Biometer Intl. A/S · Jul 1989
K904025 · MYOTRACK, MODEL HH 515
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