Cleared Traditional

K831160 - LEAD ADAPTERS #'S 6016

K831160 is the FDA 510(k) clearance for LEAD ADAPTERS #'S 6016 by Cardiac Pacemakers, Inc.. It is a Class 2 Cardiovascular device (product code DTD) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K831160 · Cardiac Pacemakers, Inc. · Cardiovascular device
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May 1983
Decision
28d
Days
Class 2
Risk

K831160 is an FDA 510(k) clearance for the LEAD ADAPTERS #'S 6016,6022,6017 ETC. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Cardiac Pacemakers, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1983 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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 Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K831160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1983
Decision Date May 09, 1983
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTD Pacemaker Lead Adaptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3620
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 - DTD Pacemaker Lead Adaptor

All 81
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K831160.
FASTPASS IMPLANTABLE ENDOCARDIAL PAC
K841885 · Pacesetter Systems · Aug 1984
IMPLANTABLE ELECTRODE BIPOLAR ADAPT
K840025 · Telectronics, Inc. · May 1984
IMPLANTABLE ELECTRODE UNIPOLAR ADAPT
K840026 · Telectronics, Inc. · May 1984
MODEL 366-07 ADAPT AID LEAD ADAPTER
K822704 · Intermedics, Inc. · Nov 1982
PACEMAKER UNIPOLAR ADAPTER
K821547 · Pacesetter Systems · Jun 1982
PACEMAKER CONNECTOR PLUG
K821548 · Pacesetter Systems · Jun 1982