Cleared Traditional

K893485 - ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR

K893485 is an FDA 510(k) clearance for ACCELOGRAPH NEUROMUSCULAR TRANSMISSION ..., manufactured by Biometer Intl. A/S. The device is a Class 2 Anesthesiology device with product code BXN cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K893485 · Biometer Intl. A/S · Anesthesiology device
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Jul 1989
Decision
85d
Days
Class 2
Risk

K893485 is an FDA 510(k) clearance for the ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR. 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 28, 1989 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biometer Intl. A/S devices

FDA 510(k) Submission Details - K893485

510(k) Number K893485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1989
Decision Date July 28, 1989
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
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 30
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K893485.
SENSI-TOUCH EPIDURAL ANESTHESIA FILTER
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K905092 · Utah Medical Products, Inc. · Jun 1991
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K883868 · Fisher & Paykel Electronics , Ltd. · Nov 1988
TRACER
K881842 · Life-Tech Intl., Inc. · Aug 1988
CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252
K882438 · Fisher &Paykel Healthcare , Ltd. · Jul 1988