510(k) Report

510(k) · Cleared

Cleared

Concentric Electrode Type #13R01, 13R02

K895460510(k) TraditionalCleared Jun 18, 1990285-day reviewClass II21 CFR 890.1385

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

Dantec Electronics, Inc. · IKT Electrode, Needle, Diagnostic Electromyograph

Cleared on Jun 18, 1990 after a 285-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jun 18, 1990
Review
285 days
Class
Class II
Product code
IKT
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared1990200020102020
  1. This deviceK895460 Concentric Electrode Type #13R01, 13R02Dantec Electronics, Inc. · 1990
  2. Descendant · cites it directly · 0 of its ownK080914 Ultrasharp Concentric NeedlesRochester Electro Medical, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K080914Ultrasharp Concentric NeedlesRochester Electro Medical, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K895460Concentric Electrode Type #13R01, 13R02Dantec Electronics, Inc.1990—
+1K080914Ultrasharp Concentric NeedlesRochester Electro Medical, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K895460, 1990–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 IKT? 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 IKT device

  1. #1 K253581 Disposable Concentric Needle Electrode…score 11.6 · 3 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K080914Ultrasharp Concentric NeedlesRochester Electro Medical, Inc.20080

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, K080914 (Rochester Electro Medical, Inc., 2008) has gone furthest, with 0 descendants of its own.

How does its category compare?

All IKT devices

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

FDA decisions per year · IKT

1in 2018

2007: 22008: 12009: 32010: 22011: 22012: 12015: 12016: 12017: 12018: 12026 (partial year): 1
2007high 3 (2009) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IKT

71in 2009

2009: 71 days median
2007high 71 (2009)2026

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

Recalls per year · IKT

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · IKT

3in 2025

2008: 22009: 72010: 52011: 72012: 72013: 122014: 92015: 52016: 72017: 82018: 252019: 152020: 32021: 52022: 42023: 82024: 92025: 3
2007high 25 (2018) · low 0 (2007)2025

MAUDE reports naming product code IKT, 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
20072—10
20081—02
200937107
20102—05
20112—07
20121—07
20130—012
20140—09
20151—05
20161—07
20171—08
20181—025
20190—015
20200—03
20210—05
20220—04
20230—08
20240—09
20250—03
20261—0—

More from Dantec Electronics, Inc.

12 FDA decisions under this applicant name. See the company

  • K894911Sensory Needle Electrode Dne 111-115,116-117,118Dantec Electronics, Inc. · 1990
  • K884915Dantec 22K60/61/62 Catheter Tip TransducerDantec Electronics, Inc. · 1989
  • K881915Dantec Magnetic StimulatorDantec Electronics, Inc. · 1988
  • K874758Dantec 13L40 ST. Marks's Pudendal ElectrodeDantec Electronics, Inc. · 1988
  • K87475913L81 Disposable Sphincter Electrode, 13L33 CableDantec Electronics, Inc. · 1988

Recent decisions in IKT

The IKT category page

  • K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode…Technomed Europe · 2026
  • K173815Allergan Botox Needle ElectrodeNatus Manufacturing Limited · 2018
  • K161430Myoject Luer Lock Needle ElectrodeNatus Manufacturing Limited · 2017
  • K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle…Bio Protech, Inc. · 2016
  • K143433Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle…Natus Manufacturing Limited · 2015

https://510kreport.com/device/K895460 · printed Nov 4, 2026

Cite this page

510(k) Report. “K895460: Concentric Electrode Type #13R01, 13R02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K895460

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