510(k) · Cleared

Cleared

Bioemg Iii

K082927510(k) TraditionalCleared Feb 6, 2009128-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

Bio-Research Associates, Inc. · KZM Device, Muscle Monitoring

Cleared on Feb 6, 2009 as substantially equivalent to K003176 (Bio-Research Associates, Inc., 2001) after a 128-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Feb 6, 2009
Review: 128 days
Class: Class II
Product code: KZM
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003176 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK003176 Bioemg II and BiojvaBio-Research Associates, Inc. · 2001
This deviceK082927 Bioemg IiiBio-Research Associates, Inc. · 2009
Descendant · cites it directly · 0 of its ownK130158 M-SCANBio-Research Associates, Inc. · 2013

Most influential descendants

Showing 1 of 1 · See all

K130158M-SCANBio-Research Associates, Inc. · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003176	Bioemg II and Biojva	Bio-Research Associates, Inc.	2001	—
0 (this device)	K082927	Bioemg Iii	Bio-Research Associates, Inc.	2009	—
+1	K130158	M-SCAN	Bio-Research Associates, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K082927, 2001–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K003176	Bioemg II and Biojva Summary page 1 …yograph + 2 channel joint vibration amplifier Classification Name: Diagnostic electromnyograph (21 CFR 890.1375, Product Code KZM and NFQ Equivalent Device: BioEMG II (K003 176) Product Description: The BioEMG III is a multi-channel electromyographic amplifier which includes; a) eight (8) identical hig…	Bio-Research Associates, Inc.	2001	—
†	K981563	Biopak Measurement System	Bio-Research Associates, Inc.	1998	—

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K130158	M-SCAN	Bio-Research Associates, Inc.	2013	0

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?

Its one ancestor has no recall.
Of its descendants, K130158 (Bio-Research Associates, Inc., 2013) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KZM devices

KZM Device, Muscle Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · KZM

1in 2016

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	0
2011	0	—	0
2012	1	—	0
2013	1	—	0
2014	0	—	0
2015	0	—	0
2016	1	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

Indications for use: 8 channel EMG amplifier 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 the diagnosis and treatments evaluation by recording the electrical activity of 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…

Read the full statement (172 words)

Indications for use: 8 channel EMG amplifier

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 the diagnosis and treatments

evaluation by recording the electrical activity of 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

Indications for Use: 2 channel JVA amplifier

1. To record and display sounds /vibrations from the temporomandibular joints

2. To aid the clinician in his analysis of a joint sound/vibration by allowing him/her to see the

waveform in various standard plots (together with K981563).

3. To aid the clinician in comparing a patient's current stand 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 /vibrations, allowing intra-patient comparisons (only) by the clinician

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082927 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082927: Bioemg Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082927

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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