Cleared Traditional

K885240 - MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD

K885240 is an FDA 510(k) clearance for MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIV..., manufactured by Tpl-Cordis, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K885240 · Tpl-Cordis, Inc. · Cardiovascular device
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Feb 1989
Decision
51d
Days
Class 3
Risk

K885240 is an FDA 510(k) clearance for the MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Tpl-Cordis, Inc. (Englewood, US). The FDA issued a Cleared decision on February 10, 1989 after a review of 51 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 Tpl-Cordis, Inc. devices

FDA 510(k) Submission Details - K885240

510(k) Number K885240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1988
Decision Date February 10, 1989
Days to Decision 51 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 125d · This submission: 51d
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 424
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K885240.
MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS
K890411 · Intermedics, Inc. · Mar 1989
MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS
K890412 · Intermedics, Inc. · Mar 1989
SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS
K890547 · Pacesetter Systems · Mar 1989
VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)
K890350 · Telectronics, Inc. · Feb 1989
MODEL 6208,6209,6210,6211,6212,6214 (PLI'S)
K890045 · Medtronic Vascular · Jan 1989
MEDTRONIC MODEL 4058 PACING LEAD
K883743 · Medtronic Vascular · Jan 1989