Cleared Traditional

K890895 - IMPLANTABLE ADAPTOR 033-380

K890895 is an FDA 510(k) clearance for IMPLANTABLE ADAPTOR 033-380, manufactured by Telectronics, Inc.. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 377-day FDA review.

K890895 · Telectronics, Inc. · Cardiovascular device
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Mar 1990
Decision
377d
Days
Class 2
Risk

K890895 is an FDA 510(k) clearance for the IMPLANTABLE ADAPTOR 033-380. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Telectronics, Inc. (Englewood, US). The FDA issued a Cleared decision on March 6, 1990 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Telectronics, Inc. devices

FDA 510(k) Submission Details - K890895

510(k) Number K890895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1989
Decision Date March 06, 1990
Days to Decision 377 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
252d slower than avg
Panel avg: 125d · This submission: 377d
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 85
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K890895.
MODEL 5866-37M LEAD ADAPTOR KIT
K904575 · Medtronic Vascular · Feb 1991
SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS
K900512 · Pacesetter Systems · Jun 1990
MODEL 5866-34 LEAD ADAPTOR KIT
K900627 · Medtronic Vascular · Apr 1990
3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100
K900605 · Possis Medical, Inc. · Mar 1990
ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP.
K894976 · Medtronic Vascular · Oct 1989
ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33
K894718 · Intermedics, Inc. · Sep 1989