Cleared Traditional

K861981 - ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR

K861981 is an FDA 510(k) clearance for ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR, manufactured by Vital Signs, Inc.. The device is a Class 2 Cardiovascular device with product code DRW cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K861981 · Vital Signs, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1986
Decision
95d
Days
Class 2
Risk

K861981 is an FDA 510(k) clearance for the ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR. Classified as Adaptor, Lead Switching, Electrocardiograph (product code DRW), Class II - Special Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on August 25, 1986 after a review of 95 days - within the typical 510(k) review window.

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 Vital Signs, Inc. devices

FDA 510(k) Submission Details - K861981

510(k) Number K861981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1986
Decision Date August 25, 1986
Days to Decision 95 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 125d · This submission: 95d
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.