BXN · Class II · 21 CFR 868.2775

FDA Product Code BXN: Stimulator, Nerve, Battery-powered

Leading manufacturers include Xavant Technology (Pty), Ltd., Life-Tech Intl., Inc. and PAJUNK GmbH Medizintechnologie.

63
Total
63
Cleared
124d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Stimulator, Nerve, Battery-powered Devices (Product Code BXN)

63 devices
1–24 of 63
Cleared Oct 16, 2022
STIMPOD NMS450 Nerve Stimulator
K213049
Xavant Technology (Pty), Ltd.
Anesthesiology · 389d
Cleared Jan 06, 2017
MultiStim ECO
K162086
PAJUNK GmbH Medizintechnologie
Anesthesiology · 163d
Cleared May 13, 2016
SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator
K153045
Easy Med Instrument Co., Ltd.
Anesthesiology · 207d
Cleared Mar 24, 2015
MiniStim MS-IVB Peripheral Nerve Stimulator
K143095
Halyard Health, Inc.
Anesthesiology · 147d
Cleared Nov 06, 2014
STIMPOD ST2-3010 NERVE STIMULATOR
K140853
Xavant Technology (Pty), Ltd.
Anesthesiology · 217d
Cleared Mar 28, 2013
EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
K121743
Sunmed, LLC
Anesthesiology · 288d
Cleared Dec 30, 2011
MYOGUIDE SYSTEM MODEL 8008
K111985
Intronix Technologies Corp.
Anesthesiology · 171d
Cleared Feb 17, 2011
STIMTRODE SINGLE USE NERVE STIMULATOR
K110118
Xavant Technology (Pty), Ltd.
Anesthesiology · 30d
Cleared Sep 03, 2009
ASCEND
K091155
Neurometrix, Inc.
Anesthesiology · 135d
Cleared Oct 17, 2006
PAJUNK MULTISTIM SENSOR NERVE STIMULATORS
K061172
PAJUNK GmbH Medizintechnologie
Anesthesiology · 173d
Cleared Nov 17, 2005
STIMUPLEX HNS-12, MODEL 4892098
K052313
Stockert GmbH
Anesthesiology · 84d
Cleared Mar 21, 2003
STIMUPLEX-DIG-RC NERVE STIMULATOR
K021033
B.Braun Medical, Inc.
Anesthesiology · 357d
Cleared Nov 29, 2001
MULTISTIM
K011308
Pajunk GmbH
Anesthesiology · 213d
Cleared Sep 28, 2001
TE ME NA POLYSTIM NERVE STIMILATOR
K990323
Te ME NA S.A.R.L.
Anesthesiology · 969d
Cleared Jan 19, 1996
SENSI-TOUCH EPIDURAL ANESTHESIA FILTER
K954525
Sherwood Medical Co.
Anesthesiology · 112d
Cleared Oct 07, 1991
MS-III MINISTIM
K913184
Life-Tech Intl., Inc.
Anesthesiology · 81d
Cleared Jun 25, 1991
NEUROMUSCULAR TRANSMISSION MONITOR
K905092
Utah Medical Products, Inc.
Anesthesiology · 223d
Cleared Nov 28, 1988
MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM
K883868
Fisher & Paykel Electronics , Ltd.
Anesthesiology · 76d
Cleared Aug 31, 1988
TRACER
K881842
Life-Tech Intl., Inc.
Anesthesiology · 121d
Cleared Jul 18, 1988
CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252
K882438
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 34d
Cleared Mar 11, 1987
MODEL MS-II MINISTIM
K870338
Life-Tech Intl., Inc.
Anesthesiology · 42d
Cleared Jun 19, 1986
MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR
K862149
Puritan Bennett Corp.
Anesthesiology · 15d
Cleared Feb 28, 1986
STIMUPLEX, NERVE STIMULATOR
K860126
Burron Medical Products, Inc.
Anesthesiology · 45d
Cleared Sep 19, 1979
BARD BIOMEDICAL NERVE LOCATOR
K791442
C.R. Bard, Inc.
Anesthesiology · 60d

About Product Code BXN - Regulatory Context

510(k) Submission Activity

63 total 510(k) submissions under product code BXN since 1976, with 63 receiving FDA clearance (average review time: 124 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.