Cleared Traditional

K801810 - PACEMAKER PATIENT MGMT. SYSTEM

K801810 is an FDA 510(k) clearance for PACEMAKER PATIENT MGMT. SYSTEM, manufactured by Siemens Elema AB. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 190-day FDA review.

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

FDA 510(k) Submission Details - K801810

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
Combination Product No
PCCP Authorized No
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.

DQK Device Classification - Class 2, Special Controls

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 260
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K801810.
KONTRON PMS 7000
K812354 · Kontron Instruments, Inc. · Sep 1981
MODEL IM1000 INTEGRATED MONITOR
K810731 · Gould, Inc. · Mar 1981
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE
K810750 · General Electric Co. · Mar 1981
DATABASE MANAGEMENT & REPORTING SYSTEM
K792677 · Honeywell, Inc. · Jan 1980
ARRHYTHMIA II EDITOR
K791776 · Spacelabs, Inc. · Oct 1979
QUINTON STATUS 1000
K782072 · Quinton, Inc. · Feb 1979