510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K991199Substantially Equivalent

Biopotential Skin Electrode, Models Bme 300, Bme 200, Bme 100, Bme 150

Biomed Products, Santa Rosa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991199 is the FDA 510(k) clearance record for BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150, a class II device, cleared for Biomed Products on under FDA product code GXY (Electrode, Cutaneous). FDA records list one 510(k) clearance for Biomed Products. As of , FDA records show no recalls naming K991199.

Clearance record

Decision date
Received
(75 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
Biomed Products 5262 Vista Grande Dr., Santa Rosa CA
510(k) summary
Statement
Third party review
No

Clearances, product code GXY

Trailing 12 months
11 clearances under product code GXY in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code GXY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20262
May 20263
June 20262
July 20261
August 20261
September 20260
October 20260