Cleared Traditional

K140020 - HYPERQ ACS-100 SYSTEM

K140020 is an FDA 510(k) clearance for HYPERQ ACS-100 SYSTEM, manufactured by Bsp-Biiological Signal Processing, Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K140020 · Bsp-Biiological Signal Processing, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
298d
Days
Class 2
Risk

K140020 is an FDA 510(k) clearance for the HYPERQ ACS-100 SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Bsp-Biiological Signal Processing, Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on October 28, 2014 after a review of 298 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 - K140020

510(k) Number K140020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2014
Decision Date October 28, 2014
Days to Decision 298 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
173d slower than avg
Panel avg: 125d · This submission: 298d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00470587 Completed Observational

Advantageous Predictors of Acute Coronary Syndromes Evaluation (APACE) Study

10000
Patients (actual)
13
Sites
Condition studied Myocardial Infarction; Angina, Unstable
Eligibility All sexes · 18 Years+
Principal investigator Christian Mueller, MD
Sponsor University Hospital, Basel, Switzerland
Started 2006-04-01 → Primary completion 2025-03-02 → Completed 2025-12-01
Primary outcome
Diagnostic utility of various biomarkers, detailed patient's history and examination as well as ECG findings for the early diagnosis of acute myocardial infarction
Study completed - no results published. This trial concluded in 2025 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - DPS Electrocardiograph

All 494
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K140020.
DIGITAL ELECTROCARDIOGRAPH
K141946 · Shenzhen Biocare Bio-Medical Equipment Co., Ltd. · Feb 2015
DIGITAL ELECTROCARDIOGRAPH
K133985 · Shenzhen Biocare Bio-Medical Equipment Co., Ltd. · Jan 2015
MAC 800 Resting ECG Analysis System
K142288 · Ge Medical Systems China Co., Ltd. · Dec 2014
ELI 380 ELECTROCARDIOGRAPH
K142105 · Mortara Instrument, Inc. · Sep 2014
CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION
K141582 · Welch Allyn · Jul 2014
DIGITAL ELECTROCARDIOGRAPH
K131858 · Guangdong Biolight Meditech Co., Ltd. · Jun 2014
K140020 · HYPERQ ACS-100 SYSTEM
Download PDF FDA Summary Bsp-Biiological Signa…