Cleared Traditional

K254000 - Happy Health Blood Pressure Monitor

K254000 is an FDA 510(k) clearance for Happy Health Blood Pressure Monitor, manufactured by Happy Health, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K254000 · Happy Health, Inc. · Cardiovascular device
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Sep 2026
Decision
262d
Days
Class 2
Risk

K254000 is an FDA 510(k) clearance for the Happy Health Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Happy Health, Inc. (Austin, US). The FDA issued a Cleared decision on September 3, 2026 after a review of 262 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Happy Health, Inc. devices

FDA 510(k) Submission Details - K254000

510(k) Number K254000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2025
Decision Date September 03, 2026
Days to Decision 262 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 125d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Rx Device Consulting
Rakesh M. Lal

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 990
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K254000.
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K261394 · Joytech Healthcare Co. , Ltd. · Aug 2026
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)
K253425 · Joytech Healthcare Co. , Ltd. · Aug 2026
BP Go (BPP-855)
K261061 · Wellvii, Inc. · Aug 2026
Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)
K261082 · Microlife Corporation · Jul 2026