510(k) Report

510(k) · Cleared

Cleared

Dantec Monopolar Lumen Electrode (13R18 and 13R19)

K950314510(k) TraditionalCleared Mar 25, 1996424-day reviewClass II21 CFR 882.1350

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dantec Medical, Inc. · GXZ Electrode, Needle

Cleared on Mar 25, 1996 after a 424-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 15 later devices descend from it.

Decided
Mar 25, 1996
Review
424 days
Class
Class II
Product code
GXZ
Recalls
None
Predicates
0

15 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2002: 1 descendant cleared2006: 1 descendant cleared2008: 1 descendant cleared2016: 1 descendant cleared2021: 3 descendants cleared2009: 1 descendant cleared2017: 1 descendant cleared2025: 1 descendant cleared2023: 1 descendant cleared2018: 1 descendant cleared2022: 2 descendants cleared1995200020052010201520202025
  1. This deviceK950314 Dantec Monopolar Lumen Electrode (13R18 and 13R19)Dantec Medical, Inc. · 1996
  2. Descendant · cites it directly · 14 of its ownK011702 Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100…Vertis Neuroscience, Inc. · 2001
  3. Descendant · 2 generations on · 13 of its ownK022241 Vertis PNT Control Unit, Model CU 100; Vertis PNT…Vertis Neuroscience, Inc. · 2002
  4. Descendant · 3 generations on · 12 of its ownK061166 Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation · 2006
  5. Descendant · 4 generations on · 11 of its ownK072123 Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008
  6. Descendant · 4 generations on · 9 of its ownK161154 Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator…Spr Therapeutics, LLC · 2016

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12006: 12008: 12009: 12016: 12017: 12018: 12021: 32022: 22023: 12025: 1
2001high 3 (2021) · low 0 (2003)2026

Most influential descendants

Showing 5 of 15 · See all
  • K011702Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, SgxxxVertis Neuroscience, Inc. · 2001 · cites it directly14descendants
  • K022241Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXXVertis Neuroscience, Inc. · 2002 · 2 generations on13descendants
  • K061166Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation · 2006 · 3 generations on12descendants
  • K072123Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008 · 4 generations on11descendants
  • K161154Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…Spr Therapeutics, LLC · 2016 · 4 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950314Dantec Monopolar Lumen Electrode (13R18 and 13R19)Dantec Medical, Inc.1996—
+1K011702Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, SgxxxVertis Neuroscience, Inc.2001—
+2K022241Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG…Vertis Neuroscience, Inc.2002—
+3K061166Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation2006—
+4K072123Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation2008—
+4K161154Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…Spr Therapeutics, LLC2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200610
200810
200910
201610
201710
201810
202130
202220
202310
202510
FIG. 1 — Lineage of K950314, 1996–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GXZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GXZ device

  1. #1 K231691 Phantom XL Insulated Dilatorsscore 10.4 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (15)

See all 15

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K011702Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, SgxxxVertis Neuroscience, Inc.200114

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K011702 (Vertis Neuroscience, Inc., 2001) has gone furthest, with 14 descendants of its own.

How does its category compare?

All GXZ devices

GXZ Electrode, Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXZ

1in 2024

2007: 32008: 22010: 12011: 22012: 12013: 22014: 22016: 12019: 22020: 12023: 22024: 1
2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXZ

102in 2007

2007: 102 days median
2007high 102 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GXZ

1in 2021

2010: 192021: 1
2007high 19 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GXZ

75in 2025

2007: 22009: 22010: 42011: 42012: 122013: 62014: 82015: 122016: 112017: 62018: 92019: 142020: 72021: 92022: 182023: 212024: 582025: 75
2007high 75 (2025) · low 0 (2008)2025

MAUDE reports naming product code GXZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007310202
20082—00
20090—02
20101—194
20112—04
20121—012
20132—06
20142—08
20150—012
20161—011
20170—06
20180—09
20192—014
20201—07
20210—19
20220—018
20232—021
20241—058
20250—075
20260—0—

More from Dantec Medical, Inc.

25 FDA decisions under this applicant name. See the company

  • K960503Dantec DuetDantec Medical, Inc. · 1996
  • K953999Dantec DA CapoDantec Medical, Inc. · 1995
  • K926363Multi-Dop SDantec Medical, Inc. · 1995
  • K931801Multi-Dop XDantec Medical, Inc. · 1995
  • K930458Multi-Dop LDantec Medical, Inc. · 1995

Recent decisions in GXZ

The GXZ category page

  • K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024
  • K232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd. · 2023
  • K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc. · 2023
  • K200984Guardian Needle ElectrodeRhythmlink International, LLC · 2020
  • K192603Spes Medica Subdermal Needle ElectrodesSpes Medica Srl · 2019

https://510kreport.com/device/K950314 · printed Nov 4, 2026

Cite this page

510(k) Report. “K950314: Dantec Monopolar Lumen Electrode (13R18 and 13R19).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950314

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026