Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
BXN — Predicate Candidate Screening
63 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
217 days90th percentile
63clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213049 | STIMPOD NMS450 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2022-10-16 | 389 | 0 |
| K162086 | MultiStim ECO | PAJUNK GmbH Medizintechnologie | 2017-01-06 | 163 | 0 |
| K153045 | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral | Easy Med Instrument Co., Ltd. | 2016-05-13 | 207 | 0 |
| K143095 | MiniStim MS-IVB Peripheral Nerve Stimulator | Halyard Health, Inc. | 2015-03-24 | 147 | 0 |
| K140853 | STIMPOD ST2-3010 NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2014-11-06 | 217 | 0 |
| K121743 | EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN | Sunmed, LLC | 2013-03-28 | 288 | 0 |
| K111985 | MYOGUIDE SYSTEM MODEL 8008 | Intronix Technologies Corp. | 2011-12-30 | 171 | 0 |
| K110118 | STIMTRODE SINGLE USE NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2011-02-17 | 30 | 0 |
| K102084 | STIMPOD NMS450 NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2010-12-16 | 143 | 0 |
| K093591 | STIMPOD MODEL NMS-400 NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2009-12-03 | 14 | 0 |
| K091155 | ASCEND | Neurometrix, Inc. | 2009-09-03 | 135 | 0 |
| K072092 | XPOD/XMAP NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | 2007-11-15 | 108 | 0 |
| K070134 | MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 | Stockert GmbH | 2007-03-22 | 65 | 0 |
| K062478 | CLAVIS | Medtronic A/S | 2007-02-08 | 168 | 0 |
| K061983 | STIMUPLEX PEN | Stockert GmbH | 2006-11-21 | 131 | 0 |
| K061172 | PAJUNK MULTISTIM SENSOR NERVE STIMULATORS | PAJUNK GmbH Medizintechnologie | 2006-10-17 | 173 | 0 |
| K052313 | STIMUPLEX HNS-12, MODEL 4892098 | Stockert GmbH | 2005-11-17 | 84 | 0 |
| K021033 | STIMUPLEX-DIG-RC NERVE STIMULATOR | B.Braun Medical, Inc. | 2003-03-21 | 357 | 0 |
| K011308 | MULTISTIM | Pajunk GmbH | 2001-11-29 | 213 | 0 |
| K990323 | TE ME NA POLYSTIM NERVE STIMILATOR | Te ME NA S.A.R.L. | 2001-09-28 | 969 | 1 |
| K003983 | STIMUPLEX HNS-11 | Stockert GmbH | 2001-06-06 | 162 | 0 |
| K954525 | SENSI-TOUCH EPIDURAL ANESTHESIA FILTER | Sherwood Medical Co. | 1996-01-19 | 112 | 0 |
| K914164 | VITALMAX 840 SERIES | Pace Tech Medical Monitors, Inc. | 1993-04-09 | 570 | 0 |
| K913184 | MS-III MINISTIM | Life-Tech Intl., Inc. | 1991-10-07 | 81 | 0 |
| K905092 | NEUROMUSCULAR TRANSMISSION MONITOR | Utah Medical Products, Inc. | 1991-06-25 | 223 | 0 |
| K904025 | MYOTRACK, MODEL HH 515 | Myotrack Co. | 1991-03-01 | 183 | 0 |
| K896368 | MODIFIED AXOSTIM | Singer Medical Products, Inc. | 1989-11-27 | 21 | 0 |
| K892396 | MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR | Biometer Intl. A/S | 1989-10-03 | 179 | 0 |
| K894786 | BIO-INDUSTRY STIM POCHE(R) | The Hader Corp. | 1989-09-29 | 59 | 0 |
| K893485 | ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR | Biometer Intl. A/S | 1989-07-28 | 85 | 0 |
| K890746 | MYOTEST DBS NERVE STIMULATOR | Biometer Intl. A/S | 1989-07-14 | 151 | 0 |
| K883807 | AXOSTIM | Singer Medical Products, Inc. | 1989-02-09 | 154 | 0 |
| K883868 | MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM | Fisher & Paykel Electronics , Ltd. | 1988-11-28 | 76 | 0 |
| K881842 | TRACER | Life-Tech Intl., Inc. | 1988-08-31 | 121 | 0 |
| K882438 | CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252 | Fisher & Paykel Healthcare, Ltd. | 1988-07-18 | 34 | 0 |
| K870619 | ACCELOGRAPH | Biometer Intl. A/S | 1987-03-16 | 32 | 0 |
| K870338 | MODEL MS-II MINISTIM | Life-Tech Intl., Inc. | 1987-03-11 | 42 | 0 |
| K864830 | TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK | Professional Instruments Co. | 1987-01-12 | 34 | 0 |
| K864829 | MODEL NS-3CC NEURO-STIM PERIPHERAL NERVE STIMULAT | Professional Instruments Co. | 1987-01-12 | 34 | 0 |
| K862149 | MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR | Puritan Bennett Corp. | 1986-06-19 | 15 | 0 |
| K861935 | MODEL 100 NERVE STIMULATOR | National Medical Sales, Inc. | 1986-06-13 | 24 | 0 |
| K860187 | MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING | Biometer Intl. A/S | 1986-03-20 | 57 | 0 |
| K860186 | MYOTEST - NERVE STIMULATOR | Biometer Intl. A/S | 1986-03-20 | 57 | 0 |
| K860126 | STIMUPLEX, NERVE STIMULATOR | Burron Medical Products, Inc. | 1986-02-28 | 45 | 4 |
| K853422 | THE GRIPPER | Regional Master Corp. | 1986-01-15 | 154 | 0 |
| K853476 | T4 MONITOR STIMULATOR COMPUTER | Regional Master Corp. | 1986-01-14 | 153 | 0 |
| K853477 | NERVE FINDER | Regional Master Corp. | 1986-01-14 | 153 | 0 |
| K853849 | MEDAR APM FORCE TRANSDUCER | Medar Corp., Inc. | 1986-01-03 | 109 | 0 |
| K852962 | PERIPHERAL NERVE STIMULATOR MODEL A400 | Fisher & Paykel Allied Products , Ltd. | 1985-12-09 | 150 | 0 |
| K843175 | NERVE STIMULATOR Q10 | Acm Systems | 1984-08-20 | 7 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda