510(k) Report

510(k) · Cleared

Cleared

Ultrasharp Concentric Needles

K080914510(k) AbbreviatedCleared Jul 15, 2008105-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

Rochester Electro Medical, Inc. · IKT Electrode, Needle, Diagnostic Electromyograph

Cleared on Jul 15, 2008 as substantially equivalent to K895460 (Dantec Electronics, Inc., 1990) and 6 other predicates after a 105-day review. Its family tree reaches back 1 generation to 1989.

Decided
Jul 15, 2008
Review
105 days
Class
Class II
Product code
IKT
Recalls
None
Predicates
7

Its longest line of descent runs back 1 generation to K896370 (1989). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1996: 1 other ancestor1994: 2 other ancestors1993: 1 other ancestor1990: 1 other ancestorK896370 · Disp. Concentric Needle Electrode (DCP-30, DCP-45) · Chalgren Enterprises, Inc. · 1989198519901995200020052010
Other ancestors, by generation 1 generation back: 6 other ancestors K896370 · Disp. Concentric Needle Electrode (DCP-30, DCP-45) · Chalgren Enterprises, Inc. · 19890
  1. Root · 1 generation backK896370 Disp. Concentric Needle Electrode (DCP-30, DCP-45)Chalgren Enterprises, Inc. · 1989
  2. This deviceK080914 Ultrasharp Concentric NeedlesRochester Electro Medical, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K896370Disp. Concentric Needle Electrode (DCP-30, DCP-45)Chalgren Enterprises, Inc.1989—
0 (this device)K080914Ultrasharp Concentric NeedlesRochester Electro Medical, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199310
199420
199610
199710
FIG. 1 — Lineage of K080914, 1989–2008Source: 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), the FDA summary (predicates and indications), 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? (7)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K895460Concentric Electrode Type #13R01, 13R02
Summary page 1
…raph; Diagnostic electromyography needle electrode; IKT Legally Marketed Predicate Device(s) 510(k) Number Product Code Trade Name Manufacturer K895460 IKT CONCENTRIC DANTEC ELECTRODE TYPE EL…
Dantec Electronics, Inc.1990—
*K931966Dantec Disposable Concentric Needle
Summary page 1
…CONCENTRIC DANTEC ELECTRODE TYPE ELECTRONICS, INC. #13R01, 13R02 931966 IKT DANTEC DISPOSABLE DANTEC MEDICAL, CONCENTRIC NEEDLE…
Dantec Medical, Inc.1994—
*K924521Disposable Concentric Needle Electrode
Summary page 1
…#13R01, 13R02 931966 IKT DANTEC DISPOSABLE DANTEC MEDICAL, CONCENTRIC NEEDLE INC. K924521 IKT DISPOSABLE CHALGREN CONCENTRIC NEEDLE…
Chalgren Enterprises, Inc.1993—
*K896370Disp. Concentric Needle Electrode (DCP-30, DCP-45)
Summary page 1
…DISPOSABLE CHALGREN CONCENTRIC NEEDLE ENTERPRISES, INC. ELECTRODE K896370 GXZ DISP. CONCENTRIC CHALGREN NEEDLE ELECTRODE…
Chalgren Enterprises, Inc.1989—
*K933795Concentric Emg Needle Electrode
Summary page 1
…ISP. CONCENTRIC CHALGREN NEEDLE ELECTRODE ENTERPRISES, INC. (DCP-30, DCP-45 K933795 GXZ CONCENTRIC EMG CADWELL NEEDLE ELECTRODE L…
Cadwell Laboratories, Inc.1994—
*K973529Neuroline, Disposable Concentric Needle Electrodes
Summary page 1
…DCP-30, DCP-45 K933795 GXZ CONCENTRIC EMG CADWELL NEEDLE ELECTRODE LABORATORIES, INC. K973529 IKT NEUROLINE, MEDICOTEST A/S. DISPOSABLE…
Medicotest A/S1997—
*K960591RE-Usable Bipolar Concentric Needle (237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP
Summary page 1
…MEDICOTEST A/S. DISPOSABLE CONCENTRIC NEEDLE ELECTRODE K960591 IKT RE-USABLE BIPOLAR CHALGREN CONCENTRIC…
Chalgren Enterprises, Inc.1996—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 7 ancestors has a recall.

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. 2008, this device’s year, is highlighted.

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—

What is it indicated for?

Recording muscle activity for Electromyography (EMG) applications. For single patient use only. Patient population: Adults.

Indications for use as stated in the FDA summary.

More from Rochester Electro Medical, Inc.

2 FDA decisions under this applicant name. See the company

  • K142159Disposable Pre-Gelled Surface ElectrodeRochester Electro Medical, Inc. · 2015

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/K080914 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080914: Ultrasharp Concentric Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080914

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026