Happy Health Blood Pressure Monitor— 510(k) K254000
Substantially EquivalentHappy Health, Inc.
FDA 510(k) clearance K254000 for Happy Health Blood Pressure Monitor, Substantially Equivalent on 2026-09-03. Applicant: Happy Health, Inc.. Device class: 2.
Summary
The Happy Health Blood Pressure Monitor is from Happy Health, filed under DXN, non-invasive blood-pressure measurement systems. The record doesn't describe its form factor or where it measures.
Class II, 21 CFR 870.1130. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).
Happy Health filed from Austin, Texas. The decision came 262 calendar days after FDA received it (December 15, 2025 to September 3, 2026).
Clearance details
- Applicant
- Happy Health, Inc.
- Product code
- Product 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
- Austin, TX, US
Recent devices under product code DXN
view all- K260670 — YUWELL® Electronic Blood Pressure Monitor
- K260470 — Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)
- K261929 — Upper Arm Blood pressure monitor (BP7155D)
- 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)
More clearances from Happy Health, Inc.
view allAdverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.