Atlas FDA

BXN

63 FDA 510(k) clearances · Product code

84 daysmedian time to decision
217 days90th percentile
63clearances measured

FDA profile

Official device name
Stimulator, Nerve, Battery-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 868.2775
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
1996: 1 · 1999: 1 · 2001: 1 · 2004: 1 · 2012: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
STIMPOD NMS450 Nerve Stimulator (K213049)Xavant Technology (Pty), Ltd.2022-10-16
MultiStim ECO (K162086)PAJUNK GmbH Medizintechnologie2017-01-06
SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator (K153045)Easy Med Instrument Co., Ltd.2016-05-13
MiniStim MS-IVB Peripheral Nerve Stimulator (K143095)Halyard Health, Inc.2015-03-24
STIMPOD ST2-3010 NERVE STIMULATOR (K140853)Xavant Technology (Pty), Ltd.2014-11-06
EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN (K121743)Sunmed, LLC2013-03-28
MYOGUIDE SYSTEM MODEL 8008 (K111985)Intronix Technologies Corp.2011-12-30
STIMTRODE SINGLE USE NERVE STIMULATOR (K110118)Xavant Technology (Pty), Ltd.2011-02-17
STIMPOD NMS450 NERVE STIMULATOR (K102084)Xavant Technology (Pty), Ltd.2010-12-16
STIMPOD MODEL NMS-400 NERVE STIMULATOR (K093591)Xavant Technology (Pty), Ltd.2009-12-03
ASCEND (K091155)Neurometrix, Inc.2009-09-03
XPOD/XMAP NERVE STIMULATOR (K072092)Xavant Technology (Pty), Ltd.2007-11-15
MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 (K070134)Stockert GmbH2007-03-22
CLAVIS (K062478)Medtronic A/S2007-02-08
STIMUPLEX PEN (K061983)Stockert GmbH2006-11-21
PAJUNK MULTISTIM SENSOR NERVE STIMULATORS (K061172)PAJUNK GmbH Medizintechnologie2006-10-17
STIMUPLEX HNS-12, MODEL 4892098 (K052313)Stockert GmbH2005-11-17
STIMUPLEX-DIG-RC NERVE STIMULATOR (K021033)B.Braun Medical, Inc.2003-03-21
MULTISTIM (K011308)Pajunk GmbH2001-11-29
TE ME NA POLYSTIM NERVE STIMILATOR (K990323)Te ME NA S.A.R.L.2001-09-28
STIMUPLEX HNS-11 (K003983)Stockert GmbH2001-06-06
SENSI-TOUCH EPIDURAL ANESTHESIA FILTER (K954525)Sherwood Medical Co.1996-01-19
VITALMAX 840 SERIES (K914164)Pace Tech Medical Monitors, Inc.1993-04-09
MS-III MINISTIM (K913184)Life-Tech Intl., Inc.1991-10-07
NEUROMUSCULAR TRANSMISSION MONITOR (K905092)Utah Medical Products, Inc.1991-06-25
MYOTRACK, MODEL HH 515 (K904025)Myotrack Co.1991-03-01
MODIFIED AXOSTIM (K896368)Singer Medical Products, Inc.1989-11-27
MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR (K892396)Biometer Intl. A/S1989-10-03
BIO-INDUSTRY STIM POCHE(R) (K894786)The Hader Corp.1989-09-29
ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR (K893485)Biometer Intl. A/S1989-07-28
MYOTEST DBS NERVE STIMULATOR (K890746)Biometer Intl. A/S1989-07-14
AXOSTIM (K883807)Singer Medical Products, Inc.1989-02-09
MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM (K883868)Fisher & Paykel Electronics , Ltd.1988-11-28
TRACER (K881842)Life-Tech Intl., Inc.1988-08-31
CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252 (K882438)Fisher & Paykel Healthcare, Ltd.1988-07-18
ACCELOGRAPH (K870619)Biometer Intl. A/S1987-03-16
MODEL MS-II MINISTIM (K870338)Life-Tech Intl., Inc.1987-03-11
TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK (K864830)Professional Instruments Co.1987-01-12
MODEL NS-3CC NEURO-STIM PERIPHERAL NERVE STIMULAT (K864829)Professional Instruments Co.1987-01-12
MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR (K862149)Puritan Bennett Corp.1986-06-19
MODEL 100 NERVE STIMULATOR (K861935)National Medical Sales, Inc.1986-06-13
MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING (K860187)Biometer Intl. A/S1986-03-20
MYOTEST - NERVE STIMULATOR (K860186)Biometer Intl. A/S1986-03-20
STIMUPLEX, NERVE STIMULATOR (K860126)Burron Medical Products, Inc.1986-02-28
THE GRIPPER (K853422)Regional Master Corp.1986-01-15
T4 MONITOR STIMULATOR COMPUTER (K853476)Regional Master Corp.1986-01-14
NERVE FINDER (K853477)Regional Master Corp.1986-01-14
MEDAR APM FORCE TRANSDUCER (K853849)Medar Corp., Inc.1986-01-03
PERIPHERAL NERVE STIMULATOR MODEL A400 (K852962)Fisher & Paykel Allied Products , Ltd.1985-12-09
NERVE STIMULATOR Q10 (K843175)Acm Systems1984-08-20
MYOGRAPH 2000 (K830058)Prothia USA, Inc.1983-03-07
MYOTEST NERVE STIMULATOR (K823583)Prothia USA, Inc.1982-12-30
STIMPEN (K822139)Neuro Technology1982-09-13
DIGISTIM II (K822137)Beuro Technology1982-07-30
PERIPHERAL NERVE STIMULATOR, MODEL A-200 (K822157)P.B. Services1982-07-30
NEUROSTIM II (K822138)Neuro Technology1982-07-30
NERVE STIMULATOR MODEL AA 1050 (K811614)Anesthesia Assoc., Inc.1981-06-18
BARD BIOMEDICAL NERVE LOCATOR (K791442)C.R. Bard, Inc.1979-09-19
NERVE STIMULATOR, DIGITAL PERIPHERAL (K791047)C.R. Bard, Inc.1979-06-13
STIMULATOR, BATTERY POWERED (K790123)Intermedics, Inc.1979-02-06
MYO-CHECK (K771765)Med General1977-09-30
NERVE STIMULATORS (K771237)Rule Medical Instruments, Inc.1977-08-02
PERIPHERAL NERVE STIMULATOR (K760614)Output, Inc.1976-11-19

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