Cleared Traditional

K882462 - PERMANENT PACING LEAD MODEL RXBJ SERIES

K882462 is an FDA 510(k) clearance for PERMANENT PACING LEAD MODEL RXBJ SERIES, manufactured by Oscor Medical Corp.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K882462 · Oscor Medical Corp. · Cardiovascular device
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Oct 1988
Decision
135d
Days
Class 3
Risk

K882462 is an FDA 510(k) clearance for the PERMANENT PACING LEAD MODEL RXBJ SERIES. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Oscor Medical Corp. (Palm Harbor, US). The FDA issued a Cleared decision on October 28, 1988 after a review of 135 days - within the typical 510(k) review window.

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 Oscor Medical Corp. devices

FDA 510(k) Submission Details - K882462

510(k) Number K882462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1988
Decision Date October 28, 1988
Days to Decision 135 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
10d slower than avg
Panel avg: 125d · This submission: 135d
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 423
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K882462.
PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F
K884394 · Ela Medical, Inc. · Dec 1988
ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED
K884005 · Medtronic Vascular · Dec 1988
PERMANENT PACING LEADS PYBJ SERIES
K882345 · Oscor Medical Corp. · Oct 1988
POLYSAFE(TM) IMPLANTABLE PACING LEAD
K884024 · Cardiac Control Systems, Inc. · Oct 1988
MEDTRONIC MODEL 4951P
K881810 · Medtronic Vascular · Oct 1988
POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP
K883015 · Cardiac Control Systems, Inc. · Oct 1988