Cleared Traditional

K890746 - MYOTEST DBS NERVE STIMULATOR

K890746 is the FDA 510(k) clearance for MYOTEST DBS NERVE STIMULATOR by Biometer Intl. A/S. It is a Class 2 Anesthesiology device (product code BXN) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K890746 · Biometer Intl. A/S · Anesthesiology device
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Jul 1989
Decision
151d
Days
Class 2
Risk

K890746 is an FDA 510(k) clearance for the MYOTEST DBS NERVE STIMULATOR. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Biometer Intl. A/S (Denmark, DK). The FDA issued a Cleared decision on July 14, 1989 after a review of 151 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.

View all Biometer Intl. A/S devices

Submission Details

510(k) Number K890746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1989
Decision Date July 14, 1989
Days to Decision 151 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 140d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K890746.
STIMPOD NMS450 Nerve Stimulator
K213049 · Xavant Technology (Pty), Ltd. · Oct 2022
STIMUPLEX-DIG-RC NERVE STIMULATOR
K021033 · B.Braun Medical, Inc. · Mar 2003
SENSI-TOUCH EPIDURAL ANESTHESIA FILTER
K954525 · Sherwood Medical Co. · Jan 1996
CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252
K882438 · Fisher &Paykel Healthcare , Ltd. · Jul 1988
MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR
K862149 · Puritan Bennett Corp. · Jun 1986
BARD BIOMEDICAL NERVE LOCATOR
K791442 · C.R. Bard, Inc. · Sep 1979