Cleared Traditional

K870619 - ACCELOGRAPH

K870619 is an FDA 510(k) clearance for ACCELOGRAPH, 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 32-day FDA review.

K870619 · Biometer Intl. A/S · Anesthesiology device
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Mar 1987
Decision
32d
Days
Class 2
Risk

K870619 is an FDA 510(k) clearance for the ACCELOGRAPH. 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 March 16, 1987 after a review of 32 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 - K870619

510(k) Number K870619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1987
Decision Date March 16, 1987
Days to Decision 32 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 140d · This submission: 32d
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 K870619.
MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM
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
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