Cleared Traditional

K011436 - MOBILE-PATIENT VIEWER

K011436 is an FDA 510(k) clearance for MOBILE-PATIENT VIEWER, manufactured by Data Critical Corporation. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K011436 · Data Critical Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K011436

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
Combination Product No
PCCP Authorized No
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.

DPS Device Classification - Class 2, Special Controls

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 571
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K011436.
MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024
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MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC
K012264 · National Custom Ent., Inc. · Oct 2001
BLY-501 ADAPTOR
K012540 · Micromedical Industries, Ltd. · Sep 2001
BCI ADVISOR VITAL SIGNS MONITOR (9200)
K011177 · Bci, Inc. · May 2001
BMT ANSCORE HEALTH MANAGEMENT SYSTEM
K010955 · Boston Medical Technologies, Inc. · Apr 2001
AB CARDIETTE START 200 HV
K010822 · H&C Medical Devices Spa · Apr 2001
K011436 · MOBILE-PATIENT VIEWER
Download PDF FDA Summary Data Critical Corpora…