MODIFICATION TO HL168— 510(k) K033043

Clearance details

Applicant

Health & Life Co., Ltd.

Product code

Code DXN

Device class

Class 2

Regulation

21 CFR 870.1130

Advisory panel

Cardiovascular

Date received

2003-09-29

Decision date

2003-10-10

Decision

Substantially Equivalent

Clearance type

Special

Location

Chung Ho City, Taipei, Hsien, TW

• 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

• K211744 — Non-Contact Infrared Thermometer, model HL710H2021-11-24
• K211127 — Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM2021-09-08
• K200521 — Full Automatic(NIBP) Blood Pressure Monitor2020-06-12
• K190507 — Full Automatic (NIBP) Blood Pressure Monitor2019-09-16
• K190133 — Full Automatic (NIBP) Blood Pressure Monitor-HL158UB2019-06-13

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 →