Cleared Traditional

K002360 - CLOUD CUFF

K002360 is an FDA 510(k) clearance for CLOUD CUFF, manufactured by Parts Port, Ltd.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K002360 · Parts Port, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
54d
Days
Class 2
Risk

K002360 is an FDA 510(k) clearance for the CLOUD CUFF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Parts Port, Ltd. (Colonial Heights, US). The FDA issued a Cleared decision on September 26, 2000 after a review of 54 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Parts Port, Ltd. devices

FDA 510(k) Submission Details - K002360

510(k) Number K002360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2000
Decision Date September 26, 2000
Days to Decision 54 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
71d faster than avg
Panel avg: 125d · This submission: 54d
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 146
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K002360.
RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS
K002954 · Rudolf Riester GmbH & Co. KG · Dec 2000
EMPIRE N BLOOD PRESSURE MANOMETERS
K002955 · Rudolf Riester GmbH & Co. KG · Dec 2000
OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010
K000512 · Cas Medical Systems, Inc. · Sep 2000
CLEEN-ABLE
K994044 · Vital Signs, Inc. · Feb 2000
WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK
K991545 · Industrielle Entwicklung Medizintechnik Und Vertri · Jan 2000
CUFF-ABLE PLUS
K990412 · Vital Signs, Inc. · Sep 1999