Cleared Abbreviated

K080854 - DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100

K080854 is an FDA 510(k) clearance for DISPOSABLE BLOOD PRESSURE CUFF, manufactured by Suntech Medical, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K080854

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.

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 133
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K080854.
UNIMED DISPOSABLE BLOOD PRESSURE CUFF
K120364 · Unimed Medical Supplies, Inc. · May 2012
UNIMED BLOOD PRESSURE CUFF
K112544 · Unimed Medical Supplies, Inc. · Nov 2011
ERKA. PERFECT-ANEROID
K103637 · Erka Kallmeyer Medizintechnik GmbH · Jun 2011
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
ALL PURPOSE CUFF, MODEL 222APC
K051904 · Suntech Medical, Inc. · Sep 2005