Cleared Special

Electronic Blood Pressure Monitor (K243661) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K243661 · Hetaida Technology Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
72d
Days
Class 2
Risk

K243661 is an FDA 510(k) clearance for the Electronic Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Hetaida Technology Co., Ltd. (Dongguan City, CN). The FDA issued a Cleared decision on February 7, 2025 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hetaida Technology Co., Ltd. devices

Submission Details

510(k) Number K243661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2024
Decision Date February 07, 2025
Days to Decision 72 days
Submission Type Special
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
53d faster than avg
Panel avg: 125d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

All 279
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K243661.
Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))
K243115 · Shenzhen Urion Technology Co., Ltd. · Feb 2025
Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)
K241578 · Shenzhen Bsx Technology Electronics Co., Ltd. · Feb 2025
Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)
K241634 · Guangdong Xinyu Electronic and Technology Co., Ltd. · Feb 2025
Accurate Mini Non-invasive blood pressure monitor (AMB-001)
K242352 · Accurate Meditech, Inc. · Feb 2025
Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)
K241590 · Guangdong Xinyu Electronic and Technology Co., Ltd. · Feb 2025
Wrist Blood Pressure Monitor (OHMS11, OHMS12)
K242568 · Shenzhen Zhongkemingwang Telecommunications Software Corp. · Jan 2025