Cleared Traditional

K972814 - LOCATOR MODEL 4036

K972814 is an FDA 510(k) clearance for LOCATOR MODEL 4036, manufactured by Pacesetter, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K972814 · Pacesetter, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
209d
Days
Class 3
Risk

K972814 is an FDA 510(k) clearance for the LOCATOR MODEL 4036. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Pacesetter, Inc. (Sylmar, US). The FDA issued a Cleared decision on February 23, 1998 after a review of 209 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 Pacesetter, Inc. devices

FDA 510(k) Submission Details - K972814

510(k) Number K972814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received July 29, 1997
Decision Date February 23, 1998
Days to Decision 209 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
84d slower than avg
Panel avg: 125d · This submission: 209d
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 K972814.
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
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
STELA MODEL UJ45 PACING LEADS
K972574 · Ela Medical, Inc. · Jan 1998
STELA MODEL BJ44 AND BJ45 PACING LEADS
K963738 · Ela Medical, Inc. · May 1997