Cleared Traditional

K210139 - Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210139 · Edan Instruments, Inc. · Cardiovascular device

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Oct 2021

Decision

255d

Days

Class 2

Risk

K210139 is an FDA 510(k) clearance for the Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on October 1, 2021 after a review of 255 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 Edan Instruments, Inc. devices

Submission Details

510(k) Number	K210139 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 19, 2021
Decision Date	October 01, 2021
Days to Decision	255 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

130d slower than avg

Panel avg: 125d · This submission: 255d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

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.