Cleared Traditional

K153033 - Digital Blood Pressure Monitor

K153033 is an FDA 510(k) clearance for Digital Blood Pressure Monitor, manufactured by Suzhou Sunspiri Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K153033 · Suzhou Sunspiri Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
249d
Days
Class 2
Risk

K153033 is an FDA 510(k) clearance for the Digital Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Suzhou Sunspiri Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on June 24, 2016 after a review of 249 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 Suzhou Sunspiri Co., Ltd. devices

FDA 510(k) Submission Details - K153033

510(k) Number K153033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2015
Decision Date June 24, 2016
Days to Decision 249 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
124d slower than avg
Panel avg: 125d · This submission: 249d
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

Shenzhen Hlongmed Biotech Company Limited
LONG YANG

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 844
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K153033.
ABPM 7100, Hypertension Management Software
K153557 · I.E.M. GmbH · Jul 2016
SunTech CT40 Spot-check Vital Signs Device
K160439 · Suntech Medical · Jul 2016
Full Automatic (NIBP) Blood Pressure Monitor
K160557 · Health & Life Co., Ltd. · Jul 2016
Full Automatic (NIBP) Blood Pressure Monitor
K161156 · Health & Life Co., Ltd. · Jun 2016
AGE Automatic Upper Arm Blood Pressure Monitor
K153552 · Ageless Health Industrial Co., Ltd. · Jun 2016
EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform
K160552 · Edwards Lifesciences, LLC · Jun 2016