Cleared Abbreviated

K080854 - DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

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 196
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K080854.
NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)
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K250765 · Avita Corporation · Sep 2025
Disposable Neonatal NIBP Cuff (U1682S-C51N)
K251045 · Unimed Medical Supplies, Inc. · Jul 2025
Disposable Blood Pressure cuff
K242623 · Shenzhen Medke Technology Co., Ltd. · Oct 2024