Cleared Traditional

K853850 - EXPLORER

K853850 is the FDA 510(k) clearance for EXPLORER by Mansfield Scientific, Inc.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K853850 · Mansfield Scientific, Inc. · Cardiovascular device
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Dec 1985
Decision
79d
Days
Class 3
Risk

K853850 is an FDA 510(k) clearance for the EXPLORER. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Mansfield Scientific, Inc. (Mansfield, US). The FDA issued a Cleared decision on December 4, 1985 after a review of 79 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 Mansfield Scientific, Inc. devices

Submission Details

510(k) Number K853850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1985
Decision Date December 04, 1985
Days to Decision 79 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 125d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 365
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K853850.
MEDTRONIC MODEL 5062
K853398 · Medtronic Vascular · Dec 1985
LIFELINE ENDOCARDIAL UNIPOLAR LEAD 483-08
K853517 · Intermedics, Inc. · Dec 1985
POLYFLEX IMPLANTABLE PACING LEAD-476-07
K853521 · Intermedics, Inc. · Dec 1985
POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD
K854071 · Intermedics, Inc. · Dec 1985
PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD
K854220 · Pacesetter Systems · Dec 1985
PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD
K854405 · Pacesetter Systems · Dec 1985