Cleared Traditional

K972574 - STELA MODEL UJ45 PACING LEADS

K972574 is the FDA 510(k) clearance for STELA MODEL UJ45 PACING LEADS by Ela Medical, Inc.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K972574 · Ela Medical, Inc. · Cardiovascular device
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Jan 1998
Decision
182d
Days
Class 3
Risk

K972574 is an FDA 510(k) clearance for the STELA MODEL UJ45 PACING LEADS. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Ela Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on January 8, 1998 after a review of 182 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 Ela Medical, Inc. devices

Submission Details

510(k) Number K972574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received July 10, 1997
Decision Date January 08, 1998
Days to Decision 182 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
57d slower than avg
Panel avg: 125d · This submission: 182d
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 386
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K972574.
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
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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
STELA MODEL BJ44 AND BJ45 PACING LEADS
K963738 · Ela Medical, Inc. · May 1997
OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR
K964107 · Oscor Medical Corp. · Apr 1997
BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION
K964604 · Biotronik, Inc. · Mar 1997