Cleared Traditional

IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY (K854997) - FDA 510(k) Clearance

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

K854997 · Telectronics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1986
Decision
62d
Days
Class 2
Risk

K854997 is an FDA 510(k) clearance for the IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Telectronics, Inc. (Suffield, US). The FDA issued a Cleared decision on February 12, 1986 after a review of 62 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 Telectronics, Inc. devices

Submission Details

510(k) Number K854997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1985
Decision Date February 12, 1986
Days to Decision 62 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 125d · This submission: 62d
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 K854997.
ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33
K894718 · Intermedics, Inc. · Sep 1989
PACEMAKER LEAD ADAPTER
K862656 · Cordis Corp. · Jul 1986
MODEL 366-08 ADAPTAID CONNECTOR ADAPTER
K860832 · Intermedics, Inc. · Mar 1986
BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE PACING LEAD
K844814 · Intermedics, Inc. · Aug 1985
MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN
K850968 · Medtronic Vascular · Aug 1985
MEDTRONIC MODEL 5561
K852356 · Medtronic Vascular · Aug 1985