Cleared Traditional

K853222 - SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD

K853222 is an FDA 510(k) clearance for SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, manufactured by Telectronics, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K853222 · Telectronics, Inc. · Cardiovascular device
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Sep 1985
Decision
47d
Days
Class 3
Risk

K853222 is an FDA 510(k) clearance for the SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-402. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Telectronics, Inc. (Suffield, US). The FDA issued a Cleared decision on September 17, 1985 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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: High-complexity regulatory submission. High regulatory complexity 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 - K853222

510(k) Number K853222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1985
Decision Date September 17, 1985
Days to Decision 47 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
78d faster than avg
Panel avg: 125d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

DTB Device Classification - Class 3, Premarket Approval

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DTB Permanent Pacemaker Electrode

All 387
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K853222.
MODEL 486-03 POLY FLEX IMPLANTABLE PACING LEAD
K853411 · Intermedics, Inc. · Oct 1985
IMPLANT ELECT LEAD, MOD 30-403 USING POLYU 90 A
K852709 · Telectronics, Inc. · Sep 1985
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD,#30-401
K853221 · Telectronics, Inc. · Sep 1985
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-407
K853223 · Telectronics, Inc. · Sep 1985
IMPLANTABLE ELECTRODE LEAD, MODEL 030-400
K852972 · Telectronics, Inc. · Sep 1985
ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860
K851731 · Ela Medical, Inc. · Aug 1985