Cleared Traditional

TE ME NA POLYSTIM NERVE STIMILATOR (K990323) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K990323 · Te ME NA S.A.R.L. · Anesthesiology device
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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

Submission Details

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
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.

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

Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K990323.
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
BARD BIOMEDICAL NERVE LOCATOR
K791442 · C.R. Bard, Inc. · Sep 1979
NERVE STIMULATOR, DIGITAL PERIPHERAL
K791047 · C.R. Bard, Inc. · Jun 1979
STIMULATOR, BATTERY POWERED
K790123 · Intermedics, Inc. · Feb 1979