Cleared Traditional

K873158 - MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS

K873158 is an FDA 510(k) clearance for MODIFIED MULTICOR AND OMNI-STANICOR PAC..., manufactured by Tpl-Cordis, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K873158 · Tpl-Cordis, Inc. · Cardiovascular device
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Jan 1988
Decision
150d
Days
Class 3
Risk

K873158 is an FDA 510(k) clearance for the MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Tpl-Cordis, Inc. (Suffield, US). The FDA issued a Cleared decision on January 7, 1988 after a review of 150 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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 Tpl-Cordis, Inc. devices

FDA 510(k) Submission Details - K873158

510(k) Number K873158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1987
Decision Date January 07, 1988
Days to Decision 150 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 125d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

DXY Device Classification - Class 3, Premarket Approval

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
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 - DXY Implantable Pacemaker Pulse-generator

All 394
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K873158.
OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D
K881837 · Telectronics, Inc. · Jul 1988
MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS
K880326 · Cardiac Control Systems, Inc. · Apr 1988
MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER
K880422 · Cardiac Control Systems, Inc. · Mar 1988
CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK.
K874158 · Cardiac Control Systems, Inc. · Dec 1987
QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.
K874394 · Intermedics, Inc. · Nov 1987
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K872766 · Telectronics, Inc. · Nov 1987