Cleared Traditional

K113239 - FULL AUTOMATIC (NIBP) BLOOD PRESSURE MO...

K113239 is an FDA 510(k) clearance for FULL AUTOMATIC (NIBP) BLOOD PRESSURE MO..., manufactured by Health & Life Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K113239 · Health & Life Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
135d
Days
Class 2
Risk

K113239 is an FDA 510(k) clearance for the FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF). Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Health & Life Co., Ltd. (Zhonghe District, New Taipei City, TW). The FDA issued a Cleared decision on March 16, 2012 after a review of 135 days - within the typical 510(k) review window.

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 Health & Life Co., Ltd. devices

FDA 510(k) Submission Details - K113239

510(k) Number K113239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2011
Decision Date March 16, 2012
Days to Decision 135 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
10d slower than avg
Panel avg: 125d · This submission: 135d
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 565
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K113239.
U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM
K120634 · Taidoc Technology Corporation · Jul 2012
FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR
K121470 · Andon Health Co, Ltd. · Jun 2012
KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR
K120672 · Andon Health Co, Ltd. · Jun 2012
FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR
K113238 · Health & Life Co., Ltd. · Mar 2012
SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR
K120132 · Philips Medical Systems · Feb 2012
VITAL SIGNS MONITOR
K120144 · Edan Instruments, Inc. · Feb 2012