Cleared Traditional

K133117 - ANDON BLOOD PRESSURE CUFF

K133117 is an FDA 510(k) clearance for ANDON BLOOD PRESSURE CUFF, manufactured by Andon Health Co, Ltd.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K133117 · Andon Health Co, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
155d
Days
Class 2
Risk

K133117 is an FDA 510(k) clearance for the ANDON BLOOD PRESSURE CUFF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on March 4, 2014 after a review of 155 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - 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.

FDA 510(k) Submission Details - K133117

510(k) Number K133117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date March 04, 2014
Days to Decision 155 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
30d slower than avg
Panel avg: 125d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXQ Device Classification - Class 2, Special Controls

Product Code DXQ Blood Pressure Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1120
Definition A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.
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 - DXQ Blood Pressure Cuff

All 186
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K133117.
SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS
K141998 · Pinghu Sama Medical Packing Co., Ltd. · Sep 2014
GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF
K140874 · Shanghai Goahui Rubber and Plastic Company · Sep 2014
SPHYGMOMANOMETER
K141392 · Suzhou JJ Meter Co., Ltd. · Jul 2014
LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF
K130942 · Legacy Medical, Inc. · Oct 2013
RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF
K123996 · Ge Medical Systems Information Technologies, Inc. · Apr 2013
FLEXIPORT ECOCUFF
K122058 · Welch Allyn, Inc. · Nov 2012
K133117 · ANDON BLOOD PRESSURE CUFF
Download PDF FDA Summary Andon Health Co, Ltd.