Cleared Traditional

K990142 - HT

K990142 is an FDA 510(k) clearance for HT, manufactured by Sulzer Oscor, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K990142 · Sulzer Oscor, Inc. · Cardiovascular device
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Jul 1999
Decision
192d
Days
Class 3
Risk

K990142 is an FDA 510(k) clearance for the HT, MODEL HT PB. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Sulzer Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on July 30, 1999 after a review of 192 days - an extended review 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 Sulzer Oscor, Inc. devices

FDA 510(k) Submission Details - K990142

510(k) Number K990142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received January 19, 1999
Decision Date July 30, 1999
Days to Decision 192 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 125d · This submission: 192d
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 397
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K990142.
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
K993448 · Ela Medical, Inc. · Apr 2000
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
K000029 · Ela Medical, Inc. · Apr 2000
YP 45/15-BP
K993139 · Biotronik, Inc. · Dec 1999
SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854
K991169 · Biotronik, Inc. · Jul 1999
RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777
K990483 · Biotronik, Inc. · Jun 1999
SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143
K980869 · Biotronik, Inc. · Sep 1998