510(k) Report

510(k) · Cleared

Cleared

Concentric Emg Needle Electrode

K933795510(k) TraditionalCleared Apr 22, 1994261-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

Cadwell Laboratories, Inc. · GXZ Electrode, Needle

Cleared on Apr 22, 1994 after a 261-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
Apr 22, 1994
Review
261 days
Class
Class II
Product code
GXZ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2008: 1 descendant cleared1990200020102020
  1. This deviceK933795 Concentric Emg Needle ElectrodeCadwell Laboratories, Inc. · 1994
  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)K933795Concentric Emg Needle ElectrodeCadwell Laboratories, Inc.1994—
+1K080914Ultrasharp Concentric NeedlesRochester Electro Medical, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K933795, 1994–2008Source: 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 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 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 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 Cadwell Laboratories, Inc.

46 FDA decisions under this applicant name. See the company

  • K061706Cadwell Easynet Oximeter ModuleCadwell Laboratories, Inc. · 2007
  • K061705Cadwell Easynet Nasal Pressure ModuleCadwell Laboratories, Inc. · 2006
  • K042350Tes-1 Constant Voltage Electrical StimulatorCadwell Laboratories, Inc. · 2004
  • K040932Easynet Body Position ModuleCadwell Laboratories, Inc. · 2004
  • K040986Cadwell Limb Movement ModuleCadwell Laboratories, Inc. · 2004

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/K933795 · printed Nov 4, 2026

Cite this page

510(k) Report. “K933795: Concentric Emg Needle Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K933795

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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