Cleared Traditional

K110525 - VITALOGRAPH MODEL 7100 - VITALOJAK (FDA 510(k) Clearance)

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

K110525 · Vitalograph (Ireland) , Ltd. · Cardiovascular device
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Nov 2011
Decision
273d
Days
Class 2
Risk

K110525 is an FDA 510(k) clearance for the VITALOGRAPH MODEL 7100 - VITALOJAK. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Vitalograph (Ireland) , Ltd. (Ennis, Co. Clare, IE). The FDA issued a Cleared decision on November 23, 2011 after a review of 273 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 Vitalograph (Ireland) , Ltd. devices

Submission Details

510(k) Number K110525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2011
Decision Date November 23, 2011
Days to Decision 273 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
148d slower than avg
Panel avg: 125d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 193
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