Automatic Upper Arm Blood Pressure Monitor— 510(k) K193627
Substantially EquivalentDongguan E-Test Technology Co., Ltd.
FDA 510(k) clearance K193627 for Automatic Upper Arm Blood Pressure Monitor, Substantially Equivalent on 2020-07-12. Applicant: Dongguan E-Test Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Dongguan E-Test Technology Co., Ltd.
- Product code
- Code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dongguan, CN
Recent devices under product code DXN
view all- K261929 — Upper Arm Blood pressure monitor (BP7155D)
- K254000 — Happy Health Blood Pressure Monitor
- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
- 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)
- 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)
More clearances from Dongguan E-Test Technology Co., Ltd.
view all- K250231 — Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)
- K193621 — Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)
- K193628 — AGE Automatic Wrist Blood Pressure Monitor
- K193624 — Automatic Upper Arm Blood Pressure Monitor
Adverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K193627
K-number listed on FDA's recall record- Z-0032-2025 — MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
- Z-0033-2025 — MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
- Z-0034-2025 — MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
- Z-1459-2024 — Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193627.
Data sourced from openFDA. This site is unofficial and independent of the FDA.