Cleared Traditional

K853771 - PINNACLE MULTI-PROGRAMMABLE PACING SYS

K853771 is an FDA 510(k) clearance for PINNACLE MULTI-PROGRAMMABLE PACING SYS, manufactured by Cardio-Pace Medical, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K853771 · Cardio-Pace Medical, Inc. · Cardiovascular device
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Jul 1986
Decision
309d
Days
Class 3
Risk

K853771 is an FDA 510(k) clearance for the PINNACLE MULTI-PROGRAMMABLE PACING SYS. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cardio-Pace Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on July 15, 1986 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Cardio-Pace Medical, Inc. devices

FDA 510(k) Submission Details - K853771

510(k) Number K853771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1985
Decision Date July 15, 1986
Days to Decision 309 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 125d · This submission: 309d
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 K853771.
NEOS VS-1, PULSE GENERATOR
K860921 · Biotronik Sales, Inc. · Aug 1986
MIKROS, MIKROS VS-1, PULSE GENERATOR
K860922 · Biotronik Sales, Inc. · Aug 1986
ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR
K860585 · Cardiac Pacemakers, Inc. · Jul 1986
MODIFIED MODELS 8320/8322/8329/8316/8317/8318
K861719 · Medtronic Vascular · Jul 1986
PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY
K861422 · Pacesetter Systems · Jun 1986
MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN
K862037 · Medtronic Vascular · Jun 1986