Cleared Abbreviated

K080854 - DISPOSABLE BLOOD PRESSURE CUFF

K080854 is the FDA 510(k) clearance for DISPOSABLE BLOOD PRESSURE CUFF by Suntech Medical, Inc.. It is a Class 2 Cardiovascular device (product code DXQ) cleared through the Abbreviated 510(k) pathway after a 207-day FDA review.

K080854 · Suntech Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
207d
Days
Class 2
Risk

K080854 is an FDA 510(k) clearance for the DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Suntech Medical, Inc. (Morrisville, US). The FDA issued a Cleared decision on October 20, 2008 after a review of 207 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 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 Suntech Medical, Inc. devices

Submission Details

510(k) Number K080854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2008
Decision Date October 20, 2008
Days to Decision 207 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 125d · This submission: 207d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 74
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K080854.
Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M
K152363 · Philips Medical Systems · Oct 2015
ANDON BLOOD PRESSURE CUFF
K133117 · Andon Health Co, Ltd. · Mar 2014
FLEXIPORT ECOCUFF
K122058 · Welch Allyn, Inc. · Nov 2012
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
KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR
K023356 · Card Guard Scientific Survival , Ltd. · Jan 2003