Cleared Traditional

K896438 - UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER

K896438 is an FDA 510(k) clearance for UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ..., manufactured by Telectronics Pacing Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K896438 · Telectronics Pacing Systems, Inc. · Cardiovascular device
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Apr 1990
Decision
152d
Days
Class 2
Risk

K896438 is an FDA 510(k) clearance for the UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Telectronics Pacing Systems, Inc. (Englewood, US). The FDA issued a Cleared decision on April 10, 1990 after a review of 152 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Pacing Systems, Inc. devices

FDA 510(k) Submission Details - K896438

510(k) Number K896438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1989
Decision Date April 10, 1990
Days to Decision 152 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
27d slower than avg
Panel avg: 125d · This submission: 152d
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 95
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K896438.
A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.
K902889 · Biotronik, GmbH & Co. · Aug 1990
SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS
K900512 · Pacesetter Systems · Jun 1990
MODEL 5866-34 LEAD ADAPTOR KIT
K900627 · Medtronic Vascular · Apr 1990
IMPLANTABLE ADAPTOR 033-380
K890895 · Telectronics, Inc. · Mar 1990
3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100
K900605 · Possis Medical, Inc. · Mar 1990
TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING
K895971 · Telectronics Pacing Systems, Inc. · Feb 1990