510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130158Substantially Equivalent

M-Scan

Bio-Research Associates, Inc., Brown Deer WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130158 is the FDA 510(k) clearance record for M-SCAN, a class II device, cleared for Bio-Research Associates, Inc. on under FDA product code KZM (Device, Muscle Monitoring). FDA records list 10 510(k) clearances for Bio-Research Associates, Inc., from to . As of , FDA records show no recalls naming K130158.

Clearance record

Decision date
Received
(183 days to decision)
Product code
KZM Device, Muscle Monitoring
Regulation
21 CFR 890.1375
Device class
Class II
Review panel
Physical Medicine
Applicant
Bio-Research Associates, Inc. 4555 W Schroeder Dr. Suite 100, Brown Deer WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KZM

Trailing 12 months

FDA records hold no clearances under product code KZM in the trailing twelve months.

FDA records show no clearances under product code KZM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KZM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260