Cleared Traditional

K980869 - SYNOX SX 53-BP

K980869 is the FDA 510(k) clearance for SYNOX SX 53-BP by Biotronik, Inc.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K980869 · Biotronik, Inc. · Cardiovascular device
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Sep 1998
Decision
188d
Days
Class 3
Risk

K980869 is an FDA 510(k) clearance for the SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120.... Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on September 10, 1998 after a review of 188 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 Biotronik, Inc. devices

Submission Details

510(k) Number K980869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1998
Decision Date September 10, 1998
Days to Decision 188 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 125d · This submission: 188d
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 352
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K980869.
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
RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000
K981083 · Biotronik, Inc. · Jul 1998
TIR/TIJ AND POLYROX
K972500 · Biotronik, Inc. · Mar 1998
ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606
K965106 · Biotronik, Inc. · Jan 1998