Cleared Traditional

K083715 - BELTBEAT WF-400

K083715 is an FDA 510(k) clearance for BELTBEAT WF-400, manufactured by Bonus Communicaciones Srl. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K083715 · Bonus Communicaciones Srl · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
274d
Days
Class 2
Risk

K083715 is an FDA 510(k) clearance for the BELTBEAT WF-400. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Bonus Communicaciones Srl (Mizpe Aviv, IL). The FDA issued a Cleared decision on September 15, 2009 after a review of 274 days - an extended review 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: 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 - K083715

510(k) Number K083715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2008
Decision Date September 15, 2009
Days to Decision 274 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
149d slower than avg
Panel avg: 125d · This submission: 274d
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 539
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K083715.
QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)
K093172 · Dynacardia, Inc. · Jan 2010
ELI 350 ELECTROCARDIOGRAPH
K092663 · Mortara Instrument, Inc. · Dec 2009
PC ECG, MODEL SE-1010
K092010 · Edan Instruments, Inc. · Oct 2009
GEM HEART ONE/ONE+
K092576 · Gem-Med S.L. · Sep 2009
SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A
K090936 · Contec Medical System Co., Ltd. · Aug 2009
SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200
K091513 · Edan Instruments, Inc. · Jul 2009
K083715 · BELTBEAT WF-400
Download PDF FDA Summary Bonus Communicaciones…