Cleared Traditional

K053006 - ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II

K053006 is an FDA 510(k) clearance for ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II, manufactured by Rossmax Internationl , Ltd.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K053006 · Rossmax Internationl , Ltd. · Cardiovascular device
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Feb 2006
Decision
100d
Days
Class 2
Risk

K053006 is an FDA 510(k) clearance for the ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Rossmax Internationl , Ltd. (Taipei, TW). The FDA issued a Cleared decision on February 3, 2006 after a review of 100 days - within the typical 510(k) review window.

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.

View all Rossmax Internationl , Ltd. devices

FDA 510(k) Submission Details - K053006

510(k) Number K053006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2005
Decision Date February 03, 2006
Days to Decision 100 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 125d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Center For Measurement Standards of Industrial

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 - DXQ Blood Pressure Cuff

All 134
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K053006.
MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF
K071244 · Medline Industries, Inc. · Mar 2008
WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
K070060 · Welch Allyn, Inc. · Dec 2007
AS101, BLOOD PRESSURE CUFF
K060871 · Wenzhou Longwan Medical Instrument Company · Jun 2006
ALL PURPOSE CUFF, MODEL 222APC
K051904 · Suntech Medical, Inc. · Sep 2005
TRICOT BLOOD PRESSURE CUFF
K051539 · Ya Horng Electronic Co., Ltd. · Aug 2005
ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A
K051021 · Shanghai Lord International Trade Co., Ltd. · Jun 2005