Cleared Traditional

K072752 - BP LIMBO XL, BPTANGO XL, BP SALSA XL

K072752 is an FDA 510(k) clearance for BP LIMBO XL, manufactured by Datadancer Medical Systems. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 400-day FDA review.

K072752 · Datadancer Medical Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
400d
Days
Class 2
Risk

K072752 is an FDA 510(k) clearance for the BP LIMBO XL, BPTANGO XL, BP SALSA XL. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Datadancer Medical Systems (Chico, US). The FDA issued a Cleared decision on October 31, 2008 after a review of 400 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Datadancer Medical Systems devices

FDA 510(k) Submission Details - K072752

510(k) Number K072752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2007
Decision Date October 31, 2008
Days to Decision 400 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
275d slower than avg
Panel avg: 125d · This submission: 400d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - DQK Computer, Diagnostic, Programmable

All 308
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K072752.
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
ENSITE FUSION DYNAMIC REGISTRATION TOOL
K082467 · St Jude Medical · Sep 2008
HORIZON XVU
K081484 · Mennen Medical , Ltd. · Jun 2008
ENSITE FUSION DYNAMIC REGISTRATION TOOL
K071818 · St Jude Medical · Dec 2007