Cleared Traditional

QUANTIEN Measurement System (K183099) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183099 · St. Jude Medical (Now Abbott Medical) · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
113d
Days
Class 2
Risk

K183099 is an FDA 510(k) clearance for the QUANTIEN Measurement System. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by St. Jude Medical (Now Abbott Medical) (St. Paul, US). The FDA issued a Cleared decision on February 28, 2019 after a review of 113 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.

View all St. Jude Medical (Now Abbott Medical) devices

Submission Details

510(k) Number K183099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2018
Decision Date February 28, 2019
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 183
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K183099.
KardiaAI
K181823 · AliveCor, Inc. · Mar 2019
RhythmAnalytics
K182344 · Biofourmis Singapore Pte., Ltd. · Mar 2019
EP-TRACER System
K183266 · Schwarzer Cardiotek GmbH · Mar 2019
AcQMap High Resolution Imaging and Mapping System
K181577 · Acutus Medical, Inc. · Feb 2019
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
K183128 · Abbott · Dec 2018
AI-ECG Platform
K180432 · Shenzhen Carewell Electronics., Ltd. · Nov 2018