510(k) Report

510(k) · Cleared

Cleared

K6-I Diagnostic System

K922456510(k) TraditionalCleared Jun 9, 1994744-day reviewClass II21 CFR 890.1375

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

Myo-Tronics, Inc. · KZM Device, Muscle Monitoring

Cleared on Jun 9, 1994 after a 744-day review. The FDA summary names no predicate by number.

Decided
Jun 9, 1994
Review
744 days
Class
Class II
Product code
KZM
Recalls
None
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K922456Source: FDA 510(k) database · 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), 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 KZM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

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.

How does its category compare?

All KZM devices

KZM Device, Muscle Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KZM

1in 2016

2009: 12012: 12013: 12016: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KZM

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

Recalls per year · KZM

No recall names KZM since 2007.

Adverse event reports per year · KZM

No MAUDE report names KZM since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20100—00
20110—00
20121—00
20131—00
20140—00
20150—00
20161—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Myo-Tronics, Inc.

6 FDA decisions under this applicant name. See the company

  • K970116Esg-1 Electrosonogram (Esg-1)Myo-Tronics, Inc. · 1997
  • K944134K6-1 Diagnostic System Version 3.1Myo-Tronics, Inc. · 1994
  • K922270Physiotech 4000 or Norodyn 8000Myo-Tronics, Inc. · 1994
  • K921919MS-100 Myo-Scanner or MS-100 Emg ScannerMyo-Tronics, Inc. · 1993
  • K905449Electrosonogram Esg-1Myo-Tronics, Inc. · 1991

Recent decisions in KZM

The KZM category page

  • K161716Teethan 2.0Bts S.P.A. · 2016
  • K130158M-SCANBio-Research Associates, Inc. · 2013
  • K113677Grindcare MeasureMedotech A/S · 2012
  • K082927Bioemg IiiBio-Research Associates, Inc. · 2009
  • K043373Dolotens Dental TM 1Neuromuscular Technologies, Inc. · 2005

https://510kreport.com/device/K922456 · printed Nov 6, 2026

Cite this page

510(k) Report. “K922456: K6-I Diagnostic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922456

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
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026