Cleared Traditional

OFF-LINE ANALYSIS SYSTEM (K921216) - FDA 510(k) Clearance

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

K921216 · Softheart, Inc. · Cardiovascular device
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Nov 1992
Decision
252d
Days
Class 2
Risk

K921216 is an FDA 510(k) clearance for the OFF-LINE ANALYSIS SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Softheart, Inc. (Charlotte, US). The FDA issued a Cleared decision on November 20, 1992 after a review of 252 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 Softheart, Inc. devices

Submission Details

510(k) Number K921216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1992
Decision Date November 20, 1992
Days to Decision 252 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 125d · This submission: 252d
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 175
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K921216.
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PHYSIOLOGICAL MEASUREMENT AND DISPLAY SYSTEMS
K920587 · Siemens Medical Solutions USA, Inc. · Jan 1993
HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST
K905100 · Hewlett-Packard Co. · Jan 1991
Q5000 PC WORKSTATION
K892113 · Quinton, Inc. · May 1989
MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM
K874171 · Hewlett-Packard Co. · Feb 1988