Not Cleared Traditional

K972500 - TIR/TIJ AND POLYROX

K972500 is an FDA 510(k) submission for TIR/TIJ AND POLYROX, manufactured by Biotronik, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K972500 · Biotronik, Inc. · Cardiovascular device
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Mar 1998
Decision
244d
Days
Class 3
Risk

K972500 is an FDA 510(k) submission (not cleared) for the TIR/TIJ AND POLYROX. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Not Cleared (DENG) decision on March 4, 1998 after a review of 244 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Cardiovascular review framework.

FDA 510(k) Submission Details - K972500

510(k) Number K972500 FDA.gov
FDA Decision Not Cleared PT (PT)
Date Received July 03, 1997
Decision Date March 04, 1998
Days to Decision 244 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
119d slower than avg
Panel avg: 125d · This submission: 244d
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 486
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K972500.
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
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
LOCATOR MODEL 4036
K972814 · Pacesetter, Inc. · Feb 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
K972500 · TIR/TIJ AND POLYROX
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