Cleared Traditional

K150908 - XM-01 Electronic Automatic Blood Pressu...

K150908 is the FDA 510(k) clearance for XM-01 Electronic Automatic Blood Pressu... by Sky Innovation Technology ( Shanghai) Limited. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K150908 · Sky Innovation Technology ( Shanghai) Limited · Cardiovascular device
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Dec 2015
Decision
257d
Days
Class 2
Risk

K150908 is an FDA 510(k) clearance for the XM-01 Electronic Automatic Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Sky Innovation Technology ( Shanghai) Limited (Shanghai, CN). The FDA issued a Cleared decision on December 16, 2015 after a review of 257 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 Sky Innovation Technology ( Shanghai) Limited devices

Submission Details

510(k) Number K150908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2015
Decision Date December 16, 2015
Days to Decision 257 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 125d · This submission: 257d
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.

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

All 501
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K150908.
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