Cleared Abbreviated

K012553 - GSIBP BLOOD PRESSURE CUFF

K012553 is an FDA 510(k) clearance for GSIBP BLOOD PRESSURE CUFF, manufactured by Globalshop, Inc.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Abbreviated 510(k) pathway after a 9-day FDA review.

K012553 · Globalshop, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
9d
Days
Class 2
Risk

K012553 is an FDA 510(k) clearance for the GSIBP BLOOD PRESSURE CUFF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Globalshop, Inc. (Ridgewood, US). The FDA issued a Cleared decision on August 17, 2001 after a review of 9 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Globalshop, Inc. devices

FDA 510(k) Submission Details - K012553

510(k) Number K012553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2001
Decision Date August 17, 2001
Days to Decision 9 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 125d · This submission: 9d
Pathway characteristics
Standards-based clearance path. 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 Peers - DXQ Blood Pressure Cuff

All 146
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K012553.
KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR
K023356 · Card Guard Scientific Survival , Ltd. · Jan 2003
SENSA-CUFF, MODELS INFANT, CHILD, ADULT
K022482 · Ge Medical Systems Information Technologies · Aug 2002
WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
K012455 · Welch Allyn, Inc. · Aug 2001
BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110
K012194 · Nihon Seimitsu Sokki Co., Ltd. · Jul 2001
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