Cleared Traditional

K872781 - EASI LEAD SYSTEM CABLE ASSEMBLY

K872781 is an FDA 510(k) clearance for EASI LEAD SYSTEM CABLE ASSEMBLY, manufactured by Totemite Medical Electronics. The device is a Class 2 Cardiovascular device with product code DRW cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K872781 · Totemite Medical Electronics · Cardiovascular device
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Dec 1987
Decision
168d
Days
Class 2
Risk

K872781 is an FDA 510(k) clearance for the EASI LEAD SYSTEM CABLE ASSEMBLY. Classified as Adaptor, Lead Switching, Electrocardiograph (product code DRW), Class II - Special Controls.

Submitted by Totemite Medical Electronics (Blaine, US). The FDA issued a Cleared decision on December 29, 1987 after a review of 168 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2350 - 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 Totemite Medical Electronics devices

FDA 510(k) Submission Details - K872781

510(k) Number K872781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1987
Decision Date December 29, 1987
Days to Decision 168 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 125d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRW Device Classification - Class 2, Special Controls

Product Code DRW Adaptor, Lead Switching, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2350
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 - DRW Adaptor, Lead Switching, Electrocardiograph

Devices cleared under the same product code (DRW) and FDA review panel - the closest regulatory comparables to K872781.
EASI ECG ALGORITHM
K033513 · Philips Medical Systems · Jan 2004
EASI 12 LEAD ALGORITHM
K020456 · Philips Medical Systems · Jul 2002
EPCOR
K930786 · Siemens Medical Solutions USA, Inc. · Sep 1994
ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR
K861981 · Vital Signs, Inc. · Aug 1986
LIMB LEAD SEL. (ECG LEAD SWITCHING AD.)
K761210 · Physio-Control Corp. · Dec 1976