Cleared Traditional

K082421 - HEARTSUITE HEMODYNAMICS 7.10

K082421 is an FDA 510(k) clearance for HEARTSUITE HEMODYNAMICS 7.10, manufactured by Emageon, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K082421 · Emageon, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
117d
Days
Class 2
Risk

K082421 is an FDA 510(k) clearance for the HEARTSUITE HEMODYNAMICS 7.10. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Emageon, Inc. (Hartland, US). The FDA issued a Cleared decision on December 17, 2008 after a review of 117 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K082421

510(k) Number K082421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2008
Decision Date December 17, 2008
Days to Decision 117 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 125d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DQK Device Classification - Class 2, Special Controls

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K082421.
ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM
K091075 · iRhythm Technologies, Inc. · Jul 2009
ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010
K083328 · St Jude Medical · May 2009
MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE
K083639 · Ge Medical Systems Information Technologies · Feb 2009
BP LIMBO XL, BPTANGO XL, BP SALSA XL
K072752 · Datadancer Medical Systems · Oct 2008
ENSITE FUSION DYNAMIC REGISTRATION TOOL
K082467 · St Jude Medical · Sep 2008
HORIZON XVU
K081484 · Mennen Medical , Ltd. · Jun 2008
K082421 · HEARTSUITE HEMODYNAMICS 7.10
Download PDF FDA Summary Emageon, Inc.