Cleared Traditional

K992524 - PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES

K992524 is an FDA 510(k) clearance for PATIENT CABLES FOR MONITORING, manufactured by Advantage Medical Electronics, Inc.. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K992524 · Advantage Medical Electronics, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
217d
Days
Class 2
Risk

K992524 is an FDA 510(k) clearance for the PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES .... Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Advantage Medical Electronics, Inc. (Coral Springs, US). The FDA issued a Cleared decision on March 1, 2000 after a review of 217 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K992524

510(k) Number K992524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1999
Decision Date March 01, 2000
Days to Decision 217 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 125d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 97
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K992524.
BIOCONNECT PATIENT MONITORING CABLES AND LEADWIRES, CAT# 1000 THRU CAT# 40000
K010809 · Rf Industries, Ltd. · May 2001
MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS
K002781 · Medical Cables, Inc. · Nov 2000
BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES
K001390 · Biosense Webster, Inc. · Jul 2000
EWC: ECG II CABLE LEADWIRE SYSTEM
K984263 · Ewc · Feb 1999
EWC: ECG CABLE AND LEADWIRE SYSTEMS
K982817 · Ewc · Sep 1998
AFFINITY MEDICAL PATIENT CABLE SYSTEM
K980806 · Affinity Medical Technologies, LLC · Mar 1998
K992524 · PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES
Download PDF FDA Summary Advantage Medical Ele…