Cleared Traditional

K855171 - TELEMETRY WAND MODEL

K855171 is an FDA 510(k) clearance for TELEMETRY WAND MODEL, manufactured by Cardiac Pacemakers, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K855171 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Jan 1986
Decision
27d
Days
Class 3
Risk

K855171 is an FDA 510(k) clearance for the TELEMETRY WAND MODEL. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cardiac Pacemakers, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 22, 1986 after a review of 27 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 Cardiac Pacemakers, Inc. devices

FDA 510(k) Submission Details - K855171

510(k) Number K855171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date January 22, 1986
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
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 393
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K855171.
CCS IMPLANTABLE MAESTRO 106/206/210 CARDIAC PACEMA
K853471 · Cardiac Control Systems, Inc. · Feb 1986
MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER.
K860202 · Cook Pacemaker Corp. · Feb 1986
MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.
K860466 · Cook Pacemaker Corp. · Feb 1986
IMPLANTABLE PROGRAMMABLE PULSE GENERATOR
K854560 · Telectronics, Inc. · Jan 1986
CORDIS MULTICOR ST, MODEL 350A
K851968 · Cordis Corp. · Jan 1986
ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER
K852641 · Sorin Biomedica, Fiat, USA, Inc. · Jan 1986