Product Code: BXN FDA class 2 21 CFR 868.2775

Stimulator, Nerve, Battery-Powered

Anesthesiology

The Stimulator, Nerve, Battery-Powered is a portable, battery-operated device that delivers controlled electrical pulses to peripheral nerves for nerve localization during regional anesthesia or monitoring of neuromuscular blockade. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BXN, regulated under 21 CFR 868.2775 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: BXN
Device Class: FDA class 2
Regulation Number: 868.2775
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 63 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K213049	STIMPOD NMS450 Nerve Stimulator	Oct 16, 2022	Substantially Equivalent	Xavant Technology (Pty), Ltd.
K162086	MultiStim ECO	Jan 06, 2017	Substantially Equivalent	PAJUNK GmbH Medizintechnologie
K153045	SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator	May 13, 2016	Substantially Equivalent	Easy Med Instrument Co., Ltd.
K143095	MiniStim MS-IVB Peripheral Nerve Stimulator	Mar 24, 2015	Substantially Equivalent	Halyard Health, Inc.
K140853	STIMPOD ST2-3010 NERVE STIMULATOR	Nov 06, 2014	Substantially Equivalent	Xavant Technology (Pty), Ltd.
K121743	EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN	Mar 28, 2013	Substantially Equivalent	Sunmed, LLC
K111985	MYOGUIDE SYSTEM MODEL 8008	Dec 30, 2011	Substantially Equivalent	Intronix Technologies Corp.
K110118	STIMTRODE SINGLE USE NERVE STIMULATOR	Feb 17, 2011	Substantially Equivalent	Xavant Technology (Pty), Ltd.
K102084	STIMPOD NMS450 NERVE STIMULATOR	Dec 16, 2010	Substantially Equivalent	Xavant Technology (Pty), Ltd.
K093591	STIMPOD MODEL NMS-400 NERVE STIMULATOR	Dec 03, 2009	Substantially Equivalent	Xavant Technology (Pty), Ltd.
K091155	ASCEND	Sep 03, 2009	Substantially Equivalent	Neurometrix, Inc.
K072092	XPOD/XMAP NERVE STIMULATOR	Nov 15, 2007	Substantially Equivalent	Xavant Technology (Pty), Ltd.
K070134	MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098	Mar 22, 2007	Substantially Equivalent	Stockert GmbH
K062478	CLAVIS	Feb 08, 2007	Substantially Equivalent	Medtronic A/S
K061983	STIMUPLEX PEN	Nov 21, 2006	Substantially Equivalent	Stockert GmbH
K061172	PAJUNK MULTISTIM SENSOR NERVE STIMULATORS	Oct 17, 2006	Substantially Equivalent	PAJUNK GmbH Medizintechnologie
K052313	STIMUPLEX HNS-12, MODEL 4892098	Nov 17, 2005	Substantially Equivalent	Stockert GmbH
K021033	STIMUPLEX-DIG-RC NERVE STIMULATOR	Mar 21, 2003	Substantially Equivalent	B.Braun Medical, Inc.
K011308	MULTISTIM	Nov 29, 2001	Substantially Equivalent	Pajunk GmbH
K990323	TE ME NA POLYSTIM NERVE STIMILATOR	Sep 28, 2001	Substantially Equivalent	Te ME NA S.A.R.L.
K003983	STIMUPLEX HNS-11	Jun 06, 2001	Substantially Equivalent	Stockert GmbH
K954525	SENSI-TOUCH EPIDURAL ANESTHESIA FILTER	Jan 19, 1996	Substantially Equivalent	Sherwood Medical Co.
K914164	VITALMAX 840 SERIES	Apr 09, 1993	Substantially Equivalent	Pace Tech Medical Monitors, Inc.
K913184	MS-III MINISTIM	Oct 07, 1991	Substantially Equivalent	Life-Tech Intl., Inc.
K905092	NEUROMUSCULAR TRANSMISSION MONITOR	Jun 25, 1991	Substantially Equivalent	Utah Medical Products, Inc.
K904025	MYOTRACK, MODEL HH 515	Mar 01, 1991	Substantially Equivalent	Myotrack Co.
K896368	MODIFIED AXOSTIM	Nov 27, 1989	Substantially Equivalent	Singer Medical Products, Inc.
K892396	MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR	Oct 03, 1989	Substantially Equivalent	Biometer Intl. A/S
K894786	BIO-INDUSTRY STIM POCHE(R)	Sep 29, 1989	Substantially Equivalent	The Hader Corp.
K893485	ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR	Jul 28, 1989	Substantially Equivalent	Biometer Intl. A/S
K890746	MYOTEST DBS NERVE STIMULATOR	Jul 14, 1989	Substantially Equivalent	Biometer Intl. A/S
K883807	AXOSTIM	Feb 09, 1989	Substantially Equivalent	Singer Medical Products, Inc.
K883868	MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM	Nov 28, 1988	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.
K881842	TRACER	Aug 31, 1988	Substantially Equivalent	Life-Tech Intl., Inc.
K882438	CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252	Jul 18, 1988	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K870619	ACCELOGRAPH	Mar 16, 1987	Substantially Equivalent	Biometer Intl. A/S
K870338	MODEL MS-II MINISTIM	Mar 11, 1987	Substantially Equivalent	Life-Tech Intl., Inc.
K864830	TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK	Jan 12, 1987	Substantially Equivalent	Professional Instruments Co.
K864829	MODEL NS-3CC NEURO-STIM PERIPHERAL NERVE STIMULAT	Jan 12, 1987	Substantially Equivalent	Professional Instruments Co.
K862149	MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR	Jun 19, 1986	Substantially Equivalent	Puritan Bennett Corp.
K861935	MODEL 100 NERVE STIMULATOR	Jun 13, 1986	Substantially Equivalent	National Medical Sales, Inc.
K860187	MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING	Mar 20, 1986	Substantially Equivalent	Biometer Intl. A/S
K860186	MYOTEST - NERVE STIMULATOR	Mar 20, 1986	Substantially Equivalent	Biometer Intl. A/S
K860126	STIMUPLEX, NERVE STIMULATOR	Feb 28, 1986	Substantially Equivalent	Burron Medical Products, Inc.
K853422	THE GRIPPER	Jan 15, 1986	Substantially Equivalent	Regional Master Corp.
K853477	NERVE FINDER	Jan 14, 1986	Substantially Equivalent	Regional Master Corp.
K853476	T4 MONITOR STIMULATOR COMPUTER	Jan 14, 1986	Substantially Equivalent	Regional Master Corp.
K853849	MEDAR APM FORCE TRANSDUCER	Jan 03, 1986	Substantially Equivalent	Medar Corp., Inc.
K852962	PERIPHERAL NERVE STIMULATOR MODEL A400	Dec 09, 1985	Substantially Equivalent	Fisher & Paykel Allied Products , Ltd.
K843175	NERVE STIMULATOR Q10	Aug 20, 1984	Substantially Equivalent	Acm Systems
K830058	MYOGRAPH 2000	Mar 07, 1983	Substantially Equivalent	Prothia USA, Inc.
K823583	MYOTEST NERVE STIMULATOR	Dec 30, 1982	Substantially Equivalent	Prothia USA, Inc.
K822139	STIMPEN	Sep 13, 1982	Substantially Equivalent	Neuro Technology
K822157	PERIPHERAL NERVE STIMULATOR, MODEL A-200	Jul 30, 1982	Substantially Equivalent	P.B. Services
K822138	NEUROSTIM II	Jul 30, 1982	Substantially Equivalent	Neuro Technology
K822137	DIGISTIM II	Jul 30, 1982	Substantially Equivalent	Beuro Technology
K811614	NERVE STIMULATOR MODEL AA 1050	Jun 18, 1981	Substantially Equivalent	Anesthesia Assoc., Inc.
K791442	BARD BIOMEDICAL NERVE LOCATOR	Sep 19, 1979	Substantially Equivalent	C.R. Bard, Inc.
K791047	NERVE STIMULATOR, DIGITAL PERIPHERAL	Jun 13, 1979	Substantially Equivalent	C.R. Bard, Inc.
K790123	STIMULATOR, BATTERY POWERED	Feb 06, 1979	Substantially Equivalent	Intermedics, Inc.
K771765	MYO-CHECK	Sep 30, 1977	Substantially Equivalent	Med General
K771237	NERVE STIMULATORS	Aug 02, 1977	Substantially Equivalent	Rule Medical Instruments, Inc.
K760614	PERIPHERAL NERVE STIMULATOR	Nov 19, 1976	Substantially Equivalent	Output, Inc.