Cleared Traditional

K813101 - CARDIOBEEPER MEMORY MONITOR

K813101 is an FDA 510(k) clearance for CARDIOBEEPER MEMORY MONITOR, manufactured by Survival Technology, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K813101 · Survival Technology, Inc. · Cardiovascular device
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Nov 1981
Decision
24d
Days
Class 3
Risk

K813101 is an FDA 510(k) clearance for the CARDIOBEEPER MEMORY MONITOR. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Survival Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1981 after a review of 24 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 Survival Technology, Inc. devices

FDA 510(k) Submission Details - K813101

510(k) Number K813101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1981
Decision Date November 27, 1981
Days to Decision 24 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 125d · This submission: 24d
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 K813101.
SIEMENS-ELEMA PULSE GENERATOR 668 B
K812610 · Siemens Corp. · Dec 1981
BIPOLAR OPTIMA MP #255
K813079 · Telectronics, Inc. · Dec 1981
DIRECTIONAL BOOT
K813150 · Pacesetter Systems · Dec 1981
MODEL 325C UNIPOLAR CARDIAC PULSE GEN.
K812832 · Cook Pacemaker Corp. · Nov 1981
MODEL 325T PROGRAMMABLE PULSE GENERATOR
K812358 · Cook Pacemaker Corp. · Oct 1981
IMPLANTABLE VENTRICULAR-INHIBITED CARDI
K812790 · Telectronics, Inc. · Oct 1981