Cleared Traditional

K822704 - MODEL 366-07 ADAPT AID LEAD ADAPTER

K822704 is an FDA 510(k) clearance for MODEL 366-07 ADAPT AID LEAD ADAPTER, manufactured by Intermedics, Inc.. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K822704 · Intermedics, Inc. · Cardiovascular device
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Nov 1982
Decision
78d
Days
Class 2
Risk

K822704 is an FDA 510(k) clearance for the MODEL 366-07 ADAPT AID LEAD ADAPTER. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Intermedics, Inc. (Walker, US). The FDA issued a Cleared decision on November 24, 1982 after a review of 78 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K822704

510(k) Number K822704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1982
Decision Date November 24, 1982
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
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 86
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K822704.
IMPLANTABLE ELECTRODE BIPOLAR ADAPT
K840025 · Telectronics, Inc. · May 1984
IMPLANTABLE ELECTRODE UNIPOLAR ADAPT
K840026 · Telectronics, Inc. · May 1984
LEAD ADAPTERS #'S 6016,6022,6017 ETC
K831160 · Cardiac Pacemakers, Inc. · May 1983
PACEMAKER UNIPOLAR ADAPTER
K821547 · Pacesetter Systems · Jun 1982
PACEMAKER CONNECTOR PLUG
K821548 · Pacesetter Systems · Jun 1982
PACEMAKER 445 ADAPTER
K821549 · Pacesetter Systems · Jun 1982