Cleared Traditional

K790436 - IMPLANTABLE HEART LEAD TERMINAL ADAPTER

K790436 is an FDA 510(k) clearance for IMPLANTABLE HEART LEAD TERMINAL ADAPTER, manufactured by Arco Medical Products Co.. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K790436 · Arco Medical Products Co. · Cardiovascular device
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May 1979
Decision
68d
Days
Class 2
Risk

K790436 is an FDA 510(k) clearance for the IMPLANTABLE HEART LEAD TERMINAL ADAPTER. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Arco Medical Products Co. (Mchenry, US). The FDA issued a Cleared decision on May 14, 1979 after a review of 68 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 Arco Medical Products Co. devices

FDA 510(k) Submission Details - K790436

510(k) Number K790436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1979
Decision Date May 14, 1979
Days to Decision 68 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
57d faster than avg
Panel avg: 125d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTD Device Classification - Class 2, Special Controls

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 93
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K790436.
GE LEAD ADAPTER, MODEL 345-01
K801040 · Intermedics, Inc. · Jun 1980
ADAPTER KIT
K800353 · Daig Corp. · May 1980
BIPOLAR LEAD ADAPTOR, MODEL BA-415
K790218 · Pacesetter Systems · Aug 1979
IMPLANTABLE HEART LEAD EXTENDER
K790468 · Arco Medical Products Co. · Mar 1979
ELECTRODE, MODEL 030-324
K781822 · Telectronics, Inc. · Feb 1979
ELECTRODE, MODEL 030-326
K781823 · Telectronics, Inc. · Feb 1979