Cleared Traditional

K823508 - LIFELINE -UNIPOLAR LEAD #487-05

K823508 is an FDA 510(k) clearance for LIFELINE -UNIPOLAR LEAD #487-05, manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K823508 · Intermedics, Inc. · Cardiovascular device
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Jan 1983
Decision
49d
Days
Class 3
Risk

K823508 is an FDA 510(k) clearance for the LIFELINE -UNIPOLAR LEAD #487-05. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 14, 1983 after a review of 49 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K823508

510(k) Number K823508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1982
Decision Date January 14, 1983
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
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 396
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K823508.
PACING LEAD #PMA F 860
K830457 · Ela Medical, Inc. · Mar 1983
PACEMAKER ELECTRODE PERM. & TEMP
K830464 · Daig Corp. · Mar 1983
LIFELINE UNIPOLAR J-LEAD #483-05
K830463 · Intermedics, Inc. · Feb 1983
ELECTRODE LEAD OF SILICONE ELASTOMETER
K823452 · Telectronics, Inc. · Jan 1983
ELECTRODE, PACEMAKER, PERMANENT
K823033 · Pacesetter Systems · Dec 1982
PRODUCTS IMPLANTABLE PACING LEAD,TINED
K823446 · Oscor, Inc. · Dec 1982