Cleared Traditional

K031970 - INFINITY MEGACARE (FDA 510(k) Clearance)

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

K031970 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 426
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K031970.
EnSite™ X EP System
K260212 · Abbott Medical · Apr 2026
ACORYS MAPPING SYSTEM
K253861 · Corify Care S.L · Apr 2026
Synchrony
K253473 · Stereotaxis, Inc. · Apr 2026
HemoSphere Nano Monitor (HSNANO1)
K253186 · Edwards Lifesciences, LLC · Feb 2026
CARTO™ 3 EP Navigation System V8.4
K252972 · Biosense Webster, Inc. · Feb 2026
IOPS Visionary System (MC-3)
K254089 · Centerline Biomedical, Inc. · Feb 2026