510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K885262Substantially Equivalent

Polyhesive Monitoring and Diagnostic Electrodes

Medtronic, Inc., Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885262 is the FDA 510(k) clearance record for POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES, a class II device, cleared for Valleylab, Inc. on under FDA product code DRX (Electrode, Electrocardiograph). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K885262.

Clearance record

Decision date
Received
(33 days to decision)
Product code
DRX Electrode, Electrocardiograph
Regulation
21 CFR 870.2360
Device class
Class II
Review panel
Cardiovascular
Applicant
Valleylab, Inc. 5920 Longbow Dr., Boulder CO
Third party review
No

Clearances, product code DRX

Trailing 12 months

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

FDA records show no clearances under product code DRX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRX, 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