Cleared Traditional

K883807 - AXOSTIM

K883807 is an FDA 510(k) clearance for AXOSTIM, manufactured by Singer Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code BXN cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K883807 · Singer Medical Products, Inc. · Anesthesiology device
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Feb 1989
Decision
154d
Days
Class 2
Risk

K883807 is an FDA 510(k) clearance for the AXOSTIM. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Singer Medical Products, Inc. (Bensenville, US). The FDA issued a Cleared decision on February 9, 1989 after a review of 154 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 - K883807

510(k) Number K883807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1988
Decision Date February 09, 1989
Days to Decision 154 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 140d · This submission: 154d
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 K883807.
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
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
K883807 · AXOSTIM
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