ESCORT NON-INVASIVE BLOOD PRESSURE OPTION— 510(k) K884742

Clearance details

Applicant

Medical Data Electronics

Product code

Code DXN

Device class

Class 2

Regulation

21 CFR 870.1130

Advisory panel

Cardiovascular

Date received

1988-11-14

Decision date

1989-02-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Arleta, CA, US

• K261929 — Upper Arm Blood pressure monitor (BP7155D)2026-09-10
• K254000 — Happy Health Blood Pressure Monitor2026-09-03
• K262658 — Automatic Digital Blood Pressure monitor (LD-526)2026-08-31
• K261394 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)2026-08-26
• K253425 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)2026-08-13

• K014294 — MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 204142002-01-25
• K012336 — MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 205002001-10-03
• K000660 — ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 204132000-03-28
• K992413 — ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR1999-08-19
• K992411 — ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR1999-08-18

Death

3

Injury

169

Malfunction

1,019

Other

2

Total

1,193

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 →