Cleared Traditional

K990323 - TE ME NA POLYSTIM NERVE STIMILATOR

K990323 is an FDA 510(k) clearance for TE ME NA POLYSTIM NERVE STIMILATOR, manufactured by Te ME NA S.A.R.L.. The device is a Class 2 Anesthesiology device with product code BXN cleared through the Traditional 510(k) pathway after a 969-day FDA review.

K990323 · Te ME NA S.A.R.L. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
969d
Days
Class 2
Risk

K990323 is an FDA 510(k) clearance for the TE ME NA POLYSTIM NERVE STIMILATOR. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Te ME NA S.A.R.L. (Oldsmar, US). The FDA issued a Cleared decision on September 28, 2001 after a review of 969 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Te ME NA S.A.R.L. devices

FDA 510(k) Submission Details - K990323

510(k) Number K990323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1999
Decision Date September 28, 2001
Days to Decision 969 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
829d slower than avg
Panel avg: 140d · This submission: 969d
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 18
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K990323.
PAJUNK MULTISTIM SENSOR NERVE STIMULATORS
K061172 · PAJUNK GmbH Medizintechnologie · Oct 2006
STIMUPLEX-DIG-RC NERVE STIMULATOR
K021033 · B.Braun Medical, Inc. · Mar 2003
MULTISTIM
K011308 · Pajunk GmbH · Nov 2001
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