Cleared Traditional

K082959 - PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS

K082959 is an FDA 510(k) clearance for PATIENT MONITORING CABLES FOR ECG, manufactured by Unimed Medical Supplies, Inc.. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K082959 · Unimed Medical Supplies, Inc. · Cardiovascular device
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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

FDA 510(k) Submission Details - K082959

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
Combination Product No
PCCP Authorized No
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.

DSA Device Classification - Class 2, Special Controls

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 Consultant

Intertek Testing Services
JAY Y KOGOMA

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 83
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K082959.
PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A
K093858 · St. Jude Medical, Cardiac Rhythm Management Divisi · Apr 2010
ADAGIO RETRACTING ECG LEAD WIRES
K093657 · Acist Medical Systems, Inc. · Jan 2010
MULTLINK CABLE AND LEADWIRE SYSTEM
K082851 · Ge Medical Systems Information Technologies · Nov 2008
CURBELL PATIENT MONITORING CABLES
K081762 · Curbell Electronics, Inc. · Aug 2008
PATIENT CABLE
K080112 · Med-Dyne · Jun 2008
SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL
K080605 · Curbell Electronics, Inc. · May 2008