Cleared Traditional

K151499 - CareTaker Continuous Non-Invasive Blood...

K151499 is an FDA 510(k) clearance for CareTaker Continuous Non-Invasive Blood..., manufactured by Caretaker Medical, LLC. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K151499 · Caretaker Medical, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
288d
Days
Class 2
Risk

K151499 is an FDA 510(k) clearance for the CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless .... Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Caretaker Medical, LLC (Charlottesville, US). The FDA issued a Cleared decision on March 18, 2016 after a review of 288 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 Caretaker Medical, LLC devices

FDA 510(k) Submission Details - K151499

510(k) Number K151499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2015
Decision Date March 18, 2016
Days to Decision 288 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
163d slower than avg
Panel avg: 125d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 567
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K151499.
Full Automatic (NIBP) Blood Pressure Monitor
K161156 · Health & Life Co., Ltd. · Jun 2016
EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform
K160552 · Edwards Lifesciences, LLC · Jun 2016
Full Automatic (NIBP) Blood Pressure Monitor
K160336 · Health & Life Co., Ltd. · Mar 2016
Full Automatic (NIBP) Blood Pressure Monitor
K160145 · Health & Life Co., Ltd. · Mar 2016
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K153077 · Microlife Intellectual Property GmbH · Feb 2016
iHealth Track Blood Pressure Monitor
K160014 · Andon Health Co, Ltd. · Feb 2016