Cleared Traditional

MOBILE-PATIENT VIEWER (K011436) - FDA 510(k) Clearance

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

K011436 · Data Critical Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
56d
Days
Class 2
Risk

K011436 is an FDA 510(k) clearance for the MOBILE-PATIENT VIEWER. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Data Critical Corporation (Tustin, US). The FDA issued a Cleared decision on July 5, 2001 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Data Critical Corporation devices

Submission Details

510(k) Number K011436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2001
Decision Date July 05, 2001
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 119
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K011436.
CARDIOFAX CE, MODEL ECG-1500 A
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CARDIOFAX CE, MODEL PEA-1110K
K042827 · Nihon Kohden America, Inc. · Jan 2005
PACEART SYSTEM
K024278 · Medtronic Vascular · May 2003
WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES
K002473 · Nihon Kohden America, Inc. · Nov 2000
QUINTON Q-STRESS, MODEL 000483
K001492 · Quinton, Inc. · Aug 2000
M1765A ECG MANAGER
K974746 · Hewlett-Packard Co. · Mar 1998