Cleared Traditional

ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33 (K894718) - FDA 510(k) Clearance

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

K894718 · Intermedics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1989
Decision
42d
Days
Class 2
Risk

K894718 is an FDA 510(k) clearance for the ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on September 5, 1989 after a review of 42 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

Submission Details

510(k) Number K894718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1989
Decision Date September 05, 1989
Days to Decision 42 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
83d faster than avg
Panel avg: 125d · This submission: 42d
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 44
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K894718.
MODEL 5866-34 LEAD ADAPTOR KIT
K900627 · Medtronic Vascular · Apr 1990
IMPLANTABLE ADAPTOR 033-380
K890895 · Telectronics, Inc. · Mar 1990
ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP.
K894976 · Medtronic Vascular · Oct 1989
PACEMAKER LEAD ADAPTER
K862656 · Cordis Corp. · Jul 1986
MODEL 366-08 ADAPTAID CONNECTOR ADAPTER
K860832 · Intermedics, Inc. · Mar 1986
IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY
K854997 · Telectronics, Inc. · Feb 1986