Cleared Traditional

K931903 - SURELOCK(TM) SNAPLESS MONITORING ELECTRODE

K931903 is an FDA 510(k) clearance for SURELOCK(TM) SNAPLESS MONITORING ELECTRODE, manufactured by Ludlow Technical Products. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K931903 · Ludlow Technical Products · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
175d
Days
Class 2
Risk

K931903 is an FDA 510(k) clearance for the SURELOCK(TM) SNAPLESS MONITORING ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Ludlow Technical Products (Chicopee, US). The FDA issued a Cleared decision on October 7, 1993 after a review of 175 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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.

View all Ludlow Technical Products devices

FDA 510(k) Submission Details - K931903

510(k) Number K931903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1993
Decision Date October 07, 1993
Days to Decision 175 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 125d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 154
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K931903.
K-KLIP
K940801 · Katecho, Inc. · Aug 1994
ZIPPREP ELECTRODE
K940802 · Aspect Medical Systems, Inc. · Jun 1994
K-SNAP
K940586 · Katecho, Inc. · Jun 1994
3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE
K930312 · 3M Health Care, Ltd. · Sep 1993
3M RED DOT 2330 RESTING EKG ELECTRODE
K932454 · 3M Health Care, Ltd. · Aug 1993
TRACET T-6000
K930258 · Lectec Corp. · Apr 1993