Cleared Traditional

PACEMAKER PATIENT MGMT. SYSTEM (K801810) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K801810 · Siemens Elema AB · Cardiovascular device
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Feb 1981
Decision
190d
Days
Class 2
Risk

K801810 is an FDA 510(k) clearance for the PACEMAKER PATIENT MGMT. SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Siemens Elema AB (Mchenry, US). The FDA issued a Cleared decision on February 5, 1981 after a review of 190 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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: Standard predicate-based submission. Standard predicate reliance. 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 Siemens Elema AB devices

Submission Details

510(k) Number K801810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1980
Decision Date February 05, 1981
Days to Decision 190 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 125d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 184
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K801810.
SIRECUST 425, RESPECTIVELY SIRECUST 430
K851637 · Siemens Medical Solutions USA, Inc. · Jul 1985
Q3000
K834567 · Quinton, Inc. · Apr 1984
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE
K810750 · General Electric Co. · Mar 1981
QUINTON STATUS 1000
K782072 · Quinton, Inc. · Feb 1979
MODEL 5621A INTERFACE
K780768 · Hewlett-Packard Co. · May 1978
AUTOMATED PHYSIOLOGIC PROFILER
K780530 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1978