Cleared Traditional

K031970 - INFINITY MEGACARE

K031970 is the FDA 510(k) clearance for INFINITY MEGACARE by Siemens Medical Solutions USA, Inc.. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K031970 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
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Sep 2003
Decision
75d
Days
Class 2
Risk

K031970 is an FDA 510(k) clearance for the INFINITY MEGACARE. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Danvers, US). The FDA issued a Cleared decision on September 9, 2003 after a review of 75 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K031970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2003
Decision Date September 09, 2003
Days to Decision 75 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 125d · This submission: 75d
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 251
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