Cleared Traditional

PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE (K810750) - FDA 510(k) Clearance

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

K810750 · General Electric Co. · Cardiovascular device
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Mar 1981
Decision
7d
Days
Class 2
Risk

K810750 is an FDA 510(k) clearance for the PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by General Electric Co. (Mchenry, US). The FDA issued a Cleared decision on March 27, 1981 after a review of 7 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all General Electric Co. devices

Submission Details

510(k) Number K810750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1981
Decision Date March 27, 1981
Days to Decision 7 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
118d faster than avg
Panel avg: 125d · This submission: 7d
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 164
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K810750.
MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM
K874171 · Hewlett-Packard Co. · Feb 1988
MICOR
K865010 · Siemens Medical Solutions USA, Inc. · Jul 1987
SIRECUST 425, RESPECTIVELY SIRECUST 430
K851637 · Siemens Medical Solutions USA, Inc. · Jul 1985
MODEL 5621A INTERFACE
K780768 · Hewlett-Packard Co. · May 1978
AUTOMATED PHYSIOLOGIC PROFILER
K780530 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1978