510(k) Report

510(k) · Cleared

Cleared

Norodyn 2000 Electromyograph

K922838510(k) TraditionalCleared Sep 22, 1993467-day reviewClass II21 CFR 882.5050

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

Noromed, Inc. · HCC Device, Biofeedback

Cleared on Sep 22, 1993 after a 467-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Sep 22, 1993
Review
467 days
Class
Class II
Product code
HCC
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 1 descendant cleared2011: 1 descendant cleared2007: 1 descendant cleared1990200020102020
  1. This deviceK922838 Norodyn 2000 ElectromyographNoromed, Inc. · 1993
  2. Descendant · cites it directly · 2 of its ownK013399 Model Mes-9000/Emg SystemMyotronics-Noromed, Inc. · 2001
  3. Descendant · 2 generations on · 0 of its ownK111687 Emg SystemMyotronics-Noromed, Inc. · 2011
  4. Descendant · 2 generations on · 0 of its ownK061828 Lorenz Biotech Aptiva, Version 2.13Lorenz Biotech S.P.A. · 2007

Most influential descendants

Showing 3 of 3 · See all
  • K013399Model Mes-9000/Emg SystemMyotronics-Noromed, Inc. · 2001 · cites it directly2descendants
  • K111687Emg SystemMyotronics-Noromed, Inc. · 2011 · 2 generations on0descendants
  • K061828Lorenz Biotech Aptiva, Version 2.13Lorenz Biotech S.P.A. · 2007 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K922838Norodyn 2000 ElectromyographNoromed, Inc.1993—
+1K013399Model Mes-9000/Emg SystemMyotronics-Noromed, Inc.2001—
+2K111687Emg SystemMyotronics-Noromed, Inc.2011—
+2K061828Lorenz Biotech Aptiva, Version 2.13Lorenz Biotech S.P.A.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200710
201110
FIG. 1 — Lineage of K922838, 1993–2011Source: 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 HCC? 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 HCC device

  1. #1 K233580 A Breathing System (ABS)score 8.1 · 2 generations · no Class I recall
  2. #2 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? (3)

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

NumberDeviceApplicantDecidedDescendants
K013399Model Mes-9000/Emg SystemMyotronics-Noromed, Inc.20012

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, K013399 (Myotronics-Noromed, Inc., 2001) has gone furthest, with 2 descendants of its own.

How does its category compare?

All HCC devices

HCC Device, Biofeedback: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HCC

1in 2024

2007: 12008: 22010: 12011: 12013: 22015: 22017: 12018: 12023: 12024: 1
2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HCC

Too few HCC 510(k)s in any year since 2007 to give a median.

Recalls per year · HCC

1in 2015

2012: 12015: 1
2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · HCC

5in 2024

2007: 22008: 22009: 12011: 42012: 22013: 22014: 22016: 42017: 32018: 12019: 62020: 22022: 32023: 22024: 5
2007high 6 (2019) · low 0 (2010)2025

MAUDE reports naming product code HCC, 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
20071—02
20082—02
20090—01
20101—00
20111—04
20120—12
20132—02
20140—02
20152—10
20160—04
20171—03
20181—01
20190—06
20200—02
20210—00
20220—03
20231—02
20241—05
20250—00
20260—0—

More from Noromed, Inc.

2 FDA decisions under this applicant name. See the company

  • K920690Norotrack 360 InclinometerNoromed, Inc. · 1992

Recent decisions in HCC

The HCC category page

  • K233580A Breathing System (ABS)Deepwell Dtx, Inc. · 2024
  • K222101PrismGraymatters Health, Ltd. · 2023
  • K180173FreespiraPalo Alto Health Sciences, Inc. · 2018
  • K163448GrindCare SystemSunstar Suisse S.A. · 2017
  • K151050Pacifier Activated Lullaby (PAL®)Power Medical Devices, LLC · 20151 recall

https://510kreport.com/device/K922838 · printed Nov 6, 2026

Cite this page

510(k) Report. “K922838: Norodyn 2000 Electromyograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922838

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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