M-Scan
Model Clench · Bio-Research Associates, Inc. · DI 00860003499962
KZM — Device, Muscle Monitoring · Class II · 21 CFR 890.1375
UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
No dated reports to chart.
Regulatory clearances
- K130158 SESE 2013-07-25 (k number procode)
Predicate lineage
K130158 — cites (transitively): K082927 (d1)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Bio-Research Associates, Inc.
- VAI 2018-03-21 Bio-Research Associates Inc. · 3 citations
- NAI 2015-04-23 Bio-Research Associates Inc. · 0 citations