3M RED DOT 2560 & 2570 MONITORING ELECTRODES— 510(k) K970796

Clearance details

Applicant

3M Healthcare

Product code

Code DRX

Device class

Class 2

Regulation

21 CFR 870.2360

Advisory panel

Cardiovascular

Date received

1997-03-04

Decision date

1997-04-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

St. Paul, MN, US

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Death

6

Injury

476

Other

2

Total

484

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0419-2021 — Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 5 electrodes per card; 1 card per pouch; 200 pouches per shipper box (1000 electrodes total).Class II·Terminated·3M Company - Health Care Business·20200915
• Z-0420-2021 — Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 3 electrodes per card; 1 card per pouch; 200 pouches per shipper box (600 electrodes total).Class II·Terminated·3M Company - Health Care Business·20200915
• Z-0421-2021 — 3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 electrodes per card; 4 cards per pouch; 20 pouches per shipper box (800 electrodes total).Class II·Terminated·3M Company - Health Care Business·20200915
• Z-0422-2021 — 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).Class II·Terminated·3M Company - Health Care Business·20200915
• Z-0423-2021 — 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).Class II·Terminated·3M Company - Health Care Business·20200915

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970796.