Cleared Traditional

ADAPTER KIT (K781864) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K781864 · Daig Corp. · Cardiovascular device
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Dec 1978
Decision
43d
Days
Class 2
Risk

K781864 is an FDA 510(k) clearance for the ADAPTER KIT. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Daig Corp. (Walker, US). The FDA issued a Cleared decision on December 19, 1978 after a review of 43 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 Daig Corp. devices

Submission Details

510(k) Number K781864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1978
Decision Date December 19, 1978
Days to Decision 43 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 125d · This submission: 43d
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 37
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K781864.
ADAPTAID HELICAL COIL ADAPTER 365-14
K801039 · Intermedics, Inc. · Jul 1980
ADAPTAID ELEMA LEAD ADAPTER KIT 365-17
K801038 · Intermedics, Inc. · Jul 1980
GE LEAD ADAPTER, MODEL 345-01
K801040 · Intermedics, Inc. · Jun 1980
LEAD ADAPTOR KIT MODEL 5866-21
K772058 · Medtronic Vascular · Nov 1977
ADAPTER, CORDIS
K770478 · Cordis Corp. · Mar 1977