Cleared Traditional

PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS (K082959) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K082959 · Unimed Medical Supplies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
7d
Days
Class 2
Risk

K082959 is an FDA 510(k) clearance for the PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Unimed Medical Supplies, Inc. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on October 10, 2008 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - 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 Unimed Medical Supplies, Inc. devices

Submission Details

510(k) Number K082959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2008
Decision Date October 10, 2008
Days to Decision 7 days
Submission Type Traditional
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
118d faster than avg
Panel avg: 125d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
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 - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 41
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K082959.
ECG Cable/Leadwires
K172797 · Shenzhen Coreray Technology, Ltd. · Feb 2018
Fixed Patient Leads ECG Cable (Model 3153)
K172591 · Boston Scientific Corporation · Nov 2017
MULTLINK CABLE AND LEADWIRE SYSTEM
K082851 · Ge Medical Systems Information Technologies · Nov 2008
REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES
K013598 · C.R. Bard, Inc. · Jan 2002
MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES
K960446 · Medtronic Vascular · May 1996
RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE
K901780 · Medtronic Vascular · Oct 1990