Cleared Traditional

K861422 - PACESETTER/SIEMENS PULSE GENERA W/VS-1 ...

K861422 is the FDA 510(k) clearance for PACESETTER/SIEMENS PULSE GENERA W/VS-1 ... by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K861422 · Pacesetter Systems · Cardiovascular device
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Jun 1986
Decision
71d
Days
Class 3
Risk

K861422 is an FDA 510(k) clearance for the PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Sylmar, US). The FDA issued a Cleared decision on June 26, 1986 after a review of 71 days - a notably fast clearance 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 Pacesetter Systems devices

Submission Details

510(k) Number K861422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1986
Decision Date June 26, 1986
Days to Decision 71 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
54d faster than avg
Panel avg: 125d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 339
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K861422.
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
MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN
K862037 · Medtronic Vascular · Jun 1986
MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER
K862038 · Medtronic Vascular · Jun 1986
MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN
K862071 · Medtronic Vascular · Jun 1986