510(k) · Cleared
ClearedBiopak Measurement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Research Associates, Inc. · KZM Device, Muscle Monitoring
Cleared on Sep 15, 1998 after a 137-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 15, 1998
- Review
- 137 days
- Class
- Class II
- Product code
- KZM
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 devicesKZM Device, Muscle Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KZM
1in 2016
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
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
At the present time, comparisons between patients of electromyograms, sonograms and / or jaw traces should not be made. Sufficient normative data have not been collected to support such population-based measurements as “mean electromyographic clench,” “standard deviation (Jaw Tracking) of freeway space,” “integral (sonograph) of sound intensity,” “average jaw tracing of chewing,” etc., for non diseased individuals as well as for patients having various…
Read the full statement (328 words)
At the present time, comparisons between patients of electromyograms, sonograms and / or jaw traces should not be made.
Sufficient normative data have not been collected to support such population-based measurements as “mean electromyographic clench,” “standard deviation (Jaw Tracking) of freeway space,” “integral (sonograph) of sound intensity,” “average jaw tracing of chewing,” etc., for non diseased individuals as well as for patients having various disease entities that are now lumped within the terminology known as ‘Temporomandibular Disorders and Associated Orofacial Pain (TMD/MPD)."
Jaw Tracking
1. To track mandibular movement and position
2. To aid in the diagnosis of TMJ/ MPD syndrome, muscle tension and bruxing [instability of occlusion]
3 To identify mandibular rest position and to identify interocclusal distance and freeway space
4. To monitor the position of the jaw in three dimensions
5. To represent the spatial position of the mandibular incisal edge relative to the skull
To provide Baseline measurements for future reference
Electromyography
1. To record electrical activity of muscles of the stomatognathic system, especially temporalis, masseter and digastric
2. To clinically monitor up to eight different muscles as an aid in diagnosis and treatment evaluation by recording the electrical activity of the muscles of the stomatognathic system.
3. To determine the degree of relaxation (intra-patient) of a single muscle / group of muscles at rest
4. To measure relative (intra-patient) levels of activity of several muscles during a functional act
To provide Baseline measurements for future reference
Sonography, joint vibration (sound) recording
1. To record and display sounds / vibrations from the temporomandibular joint
2. To aid the clinician in his analysis of a joint sound / vibration by allowing him to see the waveform in various standard plots
3. To aid the clinician in comparing a patient’s current standard plots to previous recordings before, during and after treatment
4 To provide numerical values that can be used to quantify the physical characteristics of the sounds
5. To provide Baseline measurements for future reference
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981563 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981563: Biopak Measurement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981563
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026